Back to resultsPhase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19
Primary Purpose
COVID-19
Status
Recruiting
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Covidir injections
Quantitative PCR SARS-CoV-2
IgM and IgG dosage
Screening Blood tests
Electrocardiogram
NEWS-2 score
WHO score
Physical examination
COVID-19-Related Symptoms assessment
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 75 years
- Male or female
- SARS-CoV-2 infection indicated by confirmed RT-PCR test
Moderate hospitalized COVID-19 (at least two out of three criterias below):
- Evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (X-rays)
- Oxygen saturation (SpO2) in room air < 93%
- <30 breaths per minute
- No signs of hemodynamic decompensation
- Absence of pregnancy in women of childbearing age
- Ability to understand and comply with the requirements of the protocol
- Consent to participate
- Consent to use at least one highly effective contraception methods (condoms, IUD, oral contraceptives) since the ICF signature and at least 30 days after the study.
Exclusion Criteria:
- Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are allowed to be enrolled to the study).
- Positive RT-PCR test more than 72 hours prior to enrolment.
- Onset of symptoms more than 7 days prior to enrolment.
- Participant using drugs that are under clinical investigation in last 30 days.
- Body mass index less than 19.9 or greater than 35.
- Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study.
- Concomitant HIV, HBV or HCV infection.
- Pregnancy or lactation.
- Vaccination for any other infection in the 4 weeks prior to enrolment.
- Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Sites / Locations
- Worthwhile Clinical Trials, Netcare Lakeview HospitalRecruiting
- Ahmed Al-Kadi Private Hospital,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Codivir treatment
Placebo treatment
Arm Description
20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days
Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days
Outcomes
Primary Outcome Measures
Change in World Health Organization Ordinal Scale for clinical improvement
change in World Health Organization Ordinal Scale for clinical improvement in the treatment group in comparison with Placebo. the scale min score - 0 and max score - 8. the higher the scores mean a worse outcome
Secondary Outcome Measures
Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo).
Each symptom is scored individually using the following response options and scoring values: Items 1-10: None = 0; Mild = 1; Moderate = 2; and Severe = 3 Items 11 and 12: Not at all = 0; 1-2 times = 1; 3-4 times = 2; 5 or more times = 3 Items 13 and 14: Sense of smell/taste same as usual = 0; Sense of smell/taste less than usual = 1; No sense of smell/taste = 2. he higher the scores mean a worse outcome
adverse events
Incidence and severity of adverse events related to the investigational product in the treatment group in comparison with Placebo
RT-PCR viral load
Time to decreased RT-PCR viral load in the treatment group in comparison with Placebo
IgM & IgG anti-SARS-CoV-2
Evolution of IgM & IgG anti-SARS-CoV-2 in the treatment group in comparison with Placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05218356
Brief Title
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19
Official Title
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
July 20, 2024 (Anticipated)
Study Completion Date
July 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Code Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a double-blind, multicentre, multinational study to evaluate the safety and collect preliminary efficacy data of Codivir drug product in 130 hospitalized adults with moderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smell or taste) onset must be within 7 days prior enrolment. Treatment will begin in the hospital, participants will be discharged according to medical decision and continue the treatment until to Day 7 at home and followed up to day 28.
Detailed Description
eligible hospitalized participants will be recruited to the study and will receive standard of care treatments as well as Codivir or placebo, which will be administered at a dose of 20 mg SC, twice a day, for 7 days. If up to medical decision of the medical staff in the site, the patient should be released before Day 7, site study team will contact the medical monitor of the study to get the instructions. Participants will be followed up to the 28th day via phone contact. The phone visit will be performed to monitor the clinical symptoms, collect adverse events and concomitant medication and provide the patient with additional instructions, if relevant.
If they have progressed well, they will continue the treatment up to Day 7 at home, receiving a nurse's home visit twice a day to administer Codivir and collect vital signs. Participants will be followed up to Day 28 by telemedicine. A doctor will call them periodically to monitor the clinical evolution, collect adverse events, concomitant medication and instruct the participants. In case of unfavorable evolution, the participants will remain hospitalized receiving the appropriate care. The investigator will decide whether or not the investigational medication will continue, considering the participant's health and well-being.
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
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a double-blind, multicentre, multinational study to evaluate the safety and collect preliminary efficacy data of Codivir drug product in 130 hospitalized adults with moderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smell or taste) onset must be within 7 days prior enrolment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
the study is a double-blind study: neither the participants nor the investigators will be aware of arm allocation of each study participant. Blindness is important to avoid bias. Monitoring and reporting of the success of blindness are important for the reader's confidence of the trial results. Groups should be marked by capital letter and blindness should maintain throughout the study.
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Codivir treatment
Arm Type
Experimental
Arm Description
20 mg administrated by subcutaneous (SC) injection, twice a day, for 7 days
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Placebo administrated in subcutaneous (SC) injection, twice a day, for 7 days
Intervention Type
Drug
Intervention Name(s)
Covidir injections
Other Intervention Name(s)
Experimental drug administration
Intervention Description
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a day subcutaneously at visits Day0-Day6 (7 days total)
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative PCR SARS-CoV-2
Intervention Description
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
Intervention Type
Diagnostic Test
Intervention Name(s)
IgM and IgG dosage
Intervention Description
lood collection for dosage of Anti SARS-CoV-2 antibodies.
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening Blood tests
Intervention Description
omplete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides); coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin; troponin, fibrinogen,Coagulogram (TP, aPTT); D-dimer, Pregnancy test for non-sterile women.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrocardiogram
Other Intervention Name(s)
ECG
Intervention Description
valuation by the principal investigator or assistant physician with a complete physical examination
Intervention Type
Other
Intervention Name(s)
NEWS-2 score
Intervention Description
assessment of the participant by the NEWS-2 score.
Intervention Type
Other
Intervention Name(s)
WHO score
Intervention Description
assessment of the participant by the score of the World Health Organization.
Intervention Type
Other
Intervention Name(s)
Physical examination
Intervention Description
evaluation by the principal investigator or assistant physician
Intervention Type
Other
Intervention Name(s)
COVID-19-Related Symptoms assessment
Intervention Description
will be completed by the study staff member based on patient status and answers.
Primary Outcome Measure Information:
Title
Change in World Health Organization Ordinal Scale for clinical improvement
Description
change in World Health Organization Ordinal Scale for clinical improvement in the treatment group in comparison with Placebo. the scale min score - 0 and max score - 8. the higher the scores mean a worse outcome
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Change in COVID-19-Related Symptoms score (measured on days 7, 14, 21, 28) in the treatment group in comparison with Placebo).
Description
Each symptom is scored individually using the following response options and scoring values: Items 1-10: None = 0; Mild = 1; Moderate = 2; and Severe = 3 Items 11 and 12: Not at all = 0; 1-2 times = 1; 3-4 times = 2; 5 or more times = 3 Items 13 and 14: Sense of smell/taste same as usual = 0; Sense of smell/taste less than usual = 1; No sense of smell/taste = 2. he higher the scores mean a worse outcome
Time Frame
up to 28 days
Title
adverse events
Description
Incidence and severity of adverse events related to the investigational product in the treatment group in comparison with Placebo
Time Frame
up to 28 days
Title
RT-PCR viral load
Description
Time to decreased RT-PCR viral load in the treatment group in comparison with Placebo
Time Frame
up to 28 days
Title
IgM & IgG anti-SARS-CoV-2
Description
Evolution of IgM & IgG anti-SARS-CoV-2 in the treatment group in comparison with Placebo
Time Frame
up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 75 years
Male or female
SARS-CoV-2 infection indicated by confirmed RT-PCR test
Moderate hospitalized COVID-19 (at least two out of three criterias below):
Evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (X-rays)
Oxygen saturation (SpO2) in room air < 93%
<30 breaths per minute
No signs of hemodynamic decompensation
Absence of pregnancy in women of childbearing age
Ability to understand and comply with the requirements of the protocol
Consent to participate
Consent to use at least one highly effective contraception methods (condoms, IUD, oral contraceptives) since the ICF signature and at least 30 days after the study.
Exclusion Criteria:
Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are allowed to be enrolled to the study).
Positive RT-PCR test more than 72 hours prior to enrolment.
Onset of symptoms more than 7 days prior to enrolment.
Participant using drugs that are under clinical investigation in last 30 days.
Body mass index less than 19.9 or greater than 35.
Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study.
Concomitant HIV, HBV or HCV infection.
Pregnancy or lactation.
Vaccination for any other infection in the 4 weeks prior to enrolment.
Any condition that increases the risk of participating in the study, in the opinion of the investigator.
Facility Information:
Facility Name
Worthwhile Clinical Trials, Netcare Lakeview Hospital
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr NJ Hussen Hussen, Dr
Phone
+27 (0)11 4221928
Email
drnazreen@wwct.co.za
First Name & Middle Initial & Last Name & Degree
Shamima Babooda, B.sc
Email
shamima@wwct.co.za
First Name & Middle Initial & Last Name & Degree
Dr NJ Hussen Hussen, Dr
Facility Name
Ahmed Al-Kadi Private Hospital,
City
Durban
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moosa Suleman, Dr
Phone
+27 31 492 3498/ 083 786 3007
Email
msulemanmd@gmail.com
First Name & Middle Initial & Last Name & Degree
Aadil Munga, B.sc
Email
aadilmunga@gmail.com
First Name & Middle Initial & Last Name & Degree
Moosa Suleman, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients With Moderate COVID-19
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