Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ADM03820
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Phase 2 Inclusion Criteria:
- Informed consent understood and signed prior to screening procedures
- Healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing
- Subject willing to comply with and be available for all protocol procedures for the duration of the study
- Subject determined by medical history, physical examination, and clinical judgement of the principal investigator (PI) to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria
- Subject with BMI ≥18.5 and ≤ 35 kg/m2
- Females of childbearing potential must have a negative urine pregnancy test on Day 1 prior to dosing Note: A woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy.
- Females of childbearing potential and males must agree to use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) from screening until last dose. Acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle.
- Subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing
- Clinical laboratory results within normal ranges or are no greater than Grade 1 and deemed not clinically significant by medical monitor and PI. (Any subjects with results that are Grade 2 or above according to toxicity table (modified from FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial) will be excluded)
- Subject willing to provide verifiable identification and has means to be contacted and to contact the Principal Investigator (PI) during the study.
Phase 2 Exclusion Criteria:
- History of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject
- History of diabetes (type 1 or type 2), cardiovascular disease, pulmonary disease, chronic obstructive pulmonary disease (COPD) or asthma
- History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins
- Known allergic reactions or history of anaphylaxis or any other serious adverse reactions to any of the study product components present in the formulation or in its processing, as listed in the Investigator Brochure
- Known to have HIV, HBsAg, or HCV per self-reported medical history
- Febrile illness with temperature ≥38°C within 7 days of dosing. (Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms).
- Rapid SARS CoV-2 antigen nasopharyngeal swab is positive on Day 1 prior to dosing or positive SARS-CoV-2 RT-PCR if result is received prior to dosing
- Female subject who is pregnant or breastfeeding
- Has previously received any coronavirus vaccine
- Treatment with another investigational drug or licensed live vaccine within 30 days prior to or after planned enrollment. Subjects will be informed of local availability and be eligible to obtain an authorized COVID-19 vaccine at the time of enrollment and at any time during the study
- Known history of COVID-19 infection
- Receipt of any antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin, monoclonal antibody) or blood or plasma transfusion within 6 months or within 5 half-lives of the specific antibody product given
- History of solid organ or bone marrow transplantation
- Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Use of H1 antihistamines or beta-blockers within 5 days of dosing (PRN use of H1 antihistamines may be acceptable after Medical Monitor approval)
- History of malignancy within 5 years of screening (with the exception of squamous or basal cell carcinomas of the skin, or malignancy which is considered cured with minimal risk of recurrence)
- Plans to enroll or is already enrolled in another interventional study
- Has contraindication to IM injections or blood draws e.g., bleeding disorders, use of any anti-coagulants
- Any specific condition that in the judgment of the PI precludes participation because it could affect subject safety
- Is a study site employee or staff. Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
Phase 3 Inclusion Criteria
- Informed consent understood and signed prior to screening procedures
- Healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing
- Subject has willingness to comply with and be available for all protocol procedures for the duration of the study
- Subjects determined by medical history, physical examination, and clinical judgement of the PI to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria
- Subject with BMI ≥18.5 and ≤ 40 kg/m2
- Female subjects of childbearing potential must have a negative urine pregnancy test on Day 1 prior to dosing. Note: A woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy
- Females of childbearing potential must agree to use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) from screening until last dose. Acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle
- Subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing
- Subjects' willingness to provide verifiable identification, have means to be contacted and to contact the PI during the study
Phase 3 Exclusion Criteria:
- History of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject
- History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins.
- Known allergic reactions or history of anaphylaxis or any other serious adverse reactions to any of the study product components present in the formulation or in its processing, as listed in the Investigator Brochure
- Febrile illness with temperature ≥38°C within 7 days of dosing. (Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms).
- Rapid SARS CoV-2 antigen nasopharyngeal swab positive on Day 1 prior to dosing or positive SARS-CoV-2 RT-PCR if result is received prior to dosing
- Female subject who is pregnant or breastfeeding
- Treatment with another investigational drug or licensed live vaccine within 30 days prior to or after planned enrollment. Subjects will be informed of local availability and be eligible to obtain an authorized COVID-19 vaccine at the time of enrollment and at any time during the study
- Known history of COVID-19 infection
- Receipt of any antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin, monoclonal antibody) or blood or plasma transfusion within 6 months or within 5 half-lives of the specific antibody product given
- Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Plans to enroll or is already enrolled in another interventional study 12. Has contraindication to IM injections or blood draws e.g., bleeding disorders, use of any anti-coagulants
- Has contraindication to IM injections or blood draws e.g., bleeding disorders, use of any anti-coagulants
- Any specific condition that in the judgment of the PI precludes participation because it could affect subject safety
- Is a study site employee or staff. Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High Dose IM injection of active drug or Placebo (Phase 2)
High Dose IM injection of active drug or Placebo (Phase 3)
Arm Description
Subjects will receive a high dose IM injection of either active drug or placebo. Approximately 300 subjects will receive active drug and approximately 150 subjects will receive placebo in the Phase 2 segment.
Subjects will receive a high dose IM injection of either active drug or placebo. Approximately 3000 subjects will receive active drug and approximately 1000 subjects will receive placebo in the Phase 3 segment
Outcomes
Primary Outcome Measures
Incidence and severity of reactogenicity through Day 7 and adverse events (AEs) through end of study (Phase 2)
Number of participants with AEs and reactogenicity symptoms. FDA Toxicity Grading Scale for Local and General Systemic Reactogenicity will assess severity.
Incidence of SAEs and medically-attended AEs (Phase 2)
Number of participants with SAEs and medically-attended AEs through end of study
Occurrence of changes from baseline in physical examination, vital signs, and clinical safety laboratory values (Phase 2)
Number of participants with changes from baseline
Incidence of symptomatic, virologically confirmed COVID-19 (Phase 3)
Number of participants with symptomatic, virologically confirmed COVID-19
Secondary Outcome Measures
Incidence of symptomatic, virologically confirmed COVID-19 (Phase 2 and Phase 3)
Number of participants with symptomatic, virologically confirmed COVID-19 through Day 183 (Phase 2) and through Day 57, Day 134, and Day 183 (Phase 3)
Hospitalization (Phase 2 and Phase 3)
Number of hospitalizations
All-cause mortality (Phase 2 and Phase 3)
Number of all-cause mortality
Incidence of AEs (Phase 2)
Number of participants with AEs through end of the study
Incidence of SAEs (Phase 2)
Number of participants with SAEs through end of the study
Incidence of COVID-19 related medically attended events (Phase 2)
Number of participants with events occurring after dosing through end of study
The assessment of Cmax for each of the monoclonal antibodies of ADM03820 as measured by mAb specific enzyme-linked immunosorbent assay (ELISA) (Phase 2)
Pre-dose and on Days 3, 8, 29, 57, 85, 134, 183, 232, 274 and 365
The assessment of Tmax for each of the monoclonal antibodies of ADM03820 as measured by mAb specific enzyme-linked immunosorbent assay (ELISA) (Phase 2)
Pre-dose and on Days 3, 8, 29, 57, 85, 134, 183, 232, 274 and 365
The assessment of AUC(0-t) for each of the monoclonal antibodies of ADM03820 as measured by mAb specific enzyme-linked immunosorbent assay (ELISA) (Phase 2)
Pre-dose and on Days 3, 8, 29, 57, 85, 134, 183, 232, 274 and 365
To assess SARS-CoV-2 antibody microneutralization levels (Phase 2)
Pre-dose and at Days 3, 29, and 57
To assess anti-drug antibody levels (Phase 2)
Pre-dose and on Days, 85, 134, 183, 232, 274, and 365
To assess daily COVID-19 symptoms (Phase 2)
COVID-19 daily symptoms reported by participants in diaries
SARS-CoV-2 RT-PCR assay in symptomatic subjects (Phase 2)
Severity of each symptom (Phase 3)
Severity of symptoms are assessed from Day 1 through end of study
Incidence of mild, virologically confirmed COVID-19 (Phase 3)
Number of participants with mild, virologically confirmed COVID-19 through Days 29, 57, 134 and 183
Incidence of moderate, severe, or critical virologically confirmed COVID 19 (Phase 3)
Number of participants with moderate, severe, or critical virologically confirmed COVID 19 through Days 29, 57, 134, and 183
Incidence of and severity of virologically-confirmed COVID-19 (Phase 3)
Number of participants with virologically-confirmed COVID-19 and severity of symptoms from Days 29, 57, 134, and 183 through Day 540
Incidence of AEs, SAEs, and medically attended events (Phase 3)
Number of participants with AEs, SAEs, and medically attended events through end of study
Full Information
NCT ID
NCT05142527
First Posted
December 1, 2021
Last Updated
February 1, 2023
Sponsor
Ology Bioservices
Collaborators
Enabling Biotechnologies (EB)
1. Study Identification
Unique Protocol Identification Number
NCT05142527
Brief Title
Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
Official Title
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of ADM03820 to Prevent Symptomatic COVID-19 in Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor withdrew study prior to initiation and no participants were enrolled.
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ology Bioservices
Collaborators
Enabling Biotechnologies (EB)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19 in adult subjects (≥ 18 years of age).
Detailed Description
Approximately 450 subjects will be enrolled in the Phase 2 segment of the study and will be randomized in a 2:1 ratio with a total of 300 subjects receiving ADM03820 and 150 subjects receiving placebo. In the Phase 3 segment, an additional 4,000 subjects will be enrolled and randomized in a 2:1 ratio, for a total sample size (including the Phase 2 subjects) of 4,450 total subjects.
The primary objective of the Phase 2 segment is to evaluate the safety and tolerability of ADM03820 in adult subjects. The secondary objectives are to assess safety, PK, immunogenicity, and microneutralization (MN) of ADM03820 and to gather information surrounding COVID-19 incidence rates and COVID-19 symptoms to support Phase 3 assumptions and assessment of efficacy.
The primary objectives of the Phase 3 segment are to evaluate the efficacy of ADM03820 for the prevention of symptomatic COVID-19 in adult subjects. The secondary objectives are to evaluate the efficacy of ADM03820 for prevention and amelioration of COVID-19 symptoms, to monitor the incidence and severity of COVID-19, and to evaluate the safety and tolerability of ADM03820.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose IM injection of active drug or Placebo (Phase 2)
Arm Type
Experimental
Arm Description
Subjects will receive a high dose IM injection of either active drug or placebo.
Approximately 300 subjects will receive active drug and approximately 150 subjects will receive placebo in the Phase 2 segment.
Arm Title
High Dose IM injection of active drug or Placebo (Phase 3)
Arm Type
Experimental
Arm Description
Subjects will receive a high dose IM injection of either active drug or placebo.
Approximately 3000 subjects will receive active drug and approximately 1000 subjects will receive placebo in the Phase 3 segment
Intervention Type
Drug
Intervention Name(s)
ADM03820
Intervention Description
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence and severity of reactogenicity through Day 7 and adverse events (AEs) through end of study (Phase 2)
Description
Number of participants with AEs and reactogenicity symptoms. FDA Toxicity Grading Scale for Local and General Systemic Reactogenicity will assess severity.
Time Frame
540 days
Title
Incidence of SAEs and medically-attended AEs (Phase 2)
Description
Number of participants with SAEs and medically-attended AEs through end of study
Time Frame
540 days
Title
Occurrence of changes from baseline in physical examination, vital signs, and clinical safety laboratory values (Phase 2)
Description
Number of participants with changes from baseline
Time Frame
365 days
Title
Incidence of symptomatic, virologically confirmed COVID-19 (Phase 3)
Description
Number of participants with symptomatic, virologically confirmed COVID-19
Time Frame
Day 1 to Day 29
Secondary Outcome Measure Information:
Title
Incidence of symptomatic, virologically confirmed COVID-19 (Phase 2 and Phase 3)
Description
Number of participants with symptomatic, virologically confirmed COVID-19 through Day 183 (Phase 2) and through Day 57, Day 134, and Day 183 (Phase 3)
Time Frame
183 days
Title
Hospitalization (Phase 2 and Phase 3)
Description
Number of hospitalizations
Time Frame
183 days
Title
All-cause mortality (Phase 2 and Phase 3)
Description
Number of all-cause mortality
Time Frame
183 days
Title
Incidence of AEs (Phase 2)
Description
Number of participants with AEs through end of the study
Time Frame
540 days
Title
Incidence of SAEs (Phase 2)
Description
Number of participants with SAEs through end of the study
Time Frame
540 days
Title
Incidence of COVID-19 related medically attended events (Phase 2)
Description
Number of participants with events occurring after dosing through end of study
Time Frame
540 days
Title
The assessment of Cmax for each of the monoclonal antibodies of ADM03820 as measured by mAb specific enzyme-linked immunosorbent assay (ELISA) (Phase 2)
Description
Pre-dose and on Days 3, 8, 29, 57, 85, 134, 183, 232, 274 and 365
Time Frame
365 days
Title
The assessment of Tmax for each of the monoclonal antibodies of ADM03820 as measured by mAb specific enzyme-linked immunosorbent assay (ELISA) (Phase 2)
Description
Pre-dose and on Days 3, 8, 29, 57, 85, 134, 183, 232, 274 and 365
Time Frame
365 days
Title
The assessment of AUC(0-t) for each of the monoclonal antibodies of ADM03820 as measured by mAb specific enzyme-linked immunosorbent assay (ELISA) (Phase 2)
Description
Pre-dose and on Days 3, 8, 29, 57, 85, 134, 183, 232, 274 and 365
Time Frame
365 days
Title
To assess SARS-CoV-2 antibody microneutralization levels (Phase 2)
Description
Pre-dose and at Days 3, 29, and 57
Time Frame
57 days
Title
To assess anti-drug antibody levels (Phase 2)
Description
Pre-dose and on Days, 85, 134, 183, 232, 274, and 365
Time Frame
365 days
Title
To assess daily COVID-19 symptoms (Phase 2)
Description
COVID-19 daily symptoms reported by participants in diaries
Time Frame
183 days
Title
SARS-CoV-2 RT-PCR assay in symptomatic subjects (Phase 2)
Time Frame
540 days
Title
Severity of each symptom (Phase 3)
Description
Severity of symptoms are assessed from Day 1 through end of study
Time Frame
540 days
Title
Incidence of mild, virologically confirmed COVID-19 (Phase 3)
Description
Number of participants with mild, virologically confirmed COVID-19 through Days 29, 57, 134 and 183
Time Frame
183 days
Title
Incidence of moderate, severe, or critical virologically confirmed COVID 19 (Phase 3)
Description
Number of participants with moderate, severe, or critical virologically confirmed COVID 19 through Days 29, 57, 134, and 183
Time Frame
183 days
Title
Incidence of and severity of virologically-confirmed COVID-19 (Phase 3)
Description
Number of participants with virologically-confirmed COVID-19 and severity of symptoms from Days 29, 57, 134, and 183 through Day 540
Time Frame
540 days
Title
Incidence of AEs, SAEs, and medically attended events (Phase 3)
Description
Number of participants with AEs, SAEs, and medically attended events through end of study
Time Frame
540 days
Other Pre-specified Outcome Measures:
Title
To assess Anti-SARS-CoV-2 Nucleoprotein (NP) antibody levels (Phase 2 and Phase 3)
Description
Baseline and on Days 29, 57, 183 and 274
Time Frame
274 days
Title
Serum collection for future analysis (Phase 2 and Phase 3)
Time Frame
365 days
Title
Collection of cDNA for SARS-CoV-2 sequence from subjects with positive RT-PCR assay (Phase 3)
Time Frame
540 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Phase 2 Inclusion Criteria:
Informed consent understood and signed prior to screening procedures
Healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing
Subject willing to comply with and be available for all protocol procedures for the duration of the study
Subject determined by medical history, physical examination, and clinical judgement of the principal investigator (PI) to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria
Subject with BMI ≥18.5 and ≤ 35 kg/m2
Females of childbearing potential must have a negative urine pregnancy test on Day 1 prior to dosing Note: A woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy.
Females of childbearing potential and males must agree to use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) from screening until last dose. Acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle.
Subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing
Clinical laboratory results within normal ranges or are no greater than Grade 1 and deemed not clinically significant by medical monitor and PI. (Any subjects with results that are Grade 2 or above according to toxicity table (modified from FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial) will be excluded)
Subject willing to provide verifiable identification and has means to be contacted and to contact the Principal Investigator (PI) during the study.
Phase 2 Exclusion Criteria:
History of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject
History of diabetes (type 1 or type 2), cardiovascular disease, pulmonary disease, chronic obstructive pulmonary disease (COPD) or asthma
History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins
Known allergic reactions or history of anaphylaxis or any other serious adverse reactions to any of the study product components present in the formulation or in its processing, as listed in the Investigator Brochure
Known to have HIV, HBsAg, or HCV per self-reported medical history
Febrile illness with temperature ≥38°C within 7 days of dosing. (Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms).
Rapid SARS CoV-2 antigen nasopharyngeal swab is positive on Day 1 prior to dosing or positive SARS-CoV-2 RT-PCR if result is received prior to dosing
Female subject who is pregnant or breastfeeding
Has previously received any coronavirus vaccine
Treatment with another investigational drug or licensed live vaccine within 30 days prior to or after planned enrollment. Subjects will be informed of local availability and be eligible to obtain an authorized COVID-19 vaccine at the time of enrollment and at any time during the study
Known history of COVID-19 infection
Receipt of any antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin, monoclonal antibody) or blood or plasma transfusion within 6 months or within 5 half-lives of the specific antibody product given
History of solid organ or bone marrow transplantation
Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Use of H1 antihistamines or beta-blockers within 5 days of dosing (PRN use of H1 antihistamines may be acceptable after Medical Monitor approval)
History of malignancy within 5 years of screening (with the exception of squamous or basal cell carcinomas of the skin, or malignancy which is considered cured with minimal risk of recurrence)
Plans to enroll or is already enrolled in another interventional study
Has contraindication to IM injections or blood draws e.g., bleeding disorders, use of any anti-coagulants
Any specific condition that in the judgment of the PI precludes participation because it could affect subject safety
Is a study site employee or staff. Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
Phase 3 Inclusion Criteria
Informed consent understood and signed prior to screening procedures
Healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing
Subject has willingness to comply with and be available for all protocol procedures for the duration of the study
Subjects determined by medical history, physical examination, and clinical judgement of the PI to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria
Subject with BMI ≥18.5 and ≤ 40 kg/m2
Female subjects of childbearing potential must have a negative urine pregnancy test on Day 1 prior to dosing. Note: A woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy
Females of childbearing potential must agree to use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) from screening until last dose. Acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle
Subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing
Subjects' willingness to provide verifiable identification, have means to be contacted and to contact the PI during the study
Phase 3 Exclusion Criteria:
History of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject
History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins.
Known allergic reactions or history of anaphylaxis or any other serious adverse reactions to any of the study product components present in the formulation or in its processing, as listed in the Investigator Brochure
Febrile illness with temperature ≥38°C within 7 days of dosing. (Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms).
Rapid SARS CoV-2 antigen nasopharyngeal swab positive on Day 1 prior to dosing or positive SARS-CoV-2 RT-PCR if result is received prior to dosing
Female subject who is pregnant or breastfeeding
Treatment with another investigational drug or licensed live vaccine within 30 days prior to or after planned enrollment. Subjects will be informed of local availability and be eligible to obtain an authorized COVID-19 vaccine at the time of enrollment and at any time during the study
Known history of COVID-19 infection
Receipt of any antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin, monoclonal antibody) or blood or plasma transfusion within 6 months or within 5 half-lives of the specific antibody product given
Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Plans to enroll or is already enrolled in another interventional study 12. Has contraindication to IM injections or blood draws e.g., bleeding disorders, use of any anti-coagulants
Has contraindication to IM injections or blood draws e.g., bleeding disorders, use of any anti-coagulants
Any specific condition that in the judgment of the PI precludes participation because it could affect subject safety
Is a study site employee or staff. Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
12. IPD Sharing Statement
Citations:
PubMed Identifier
35713300
Citation
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
We'll reach out to this number within 24 hrs