Back to resultsTrial of Combination Therapy to Treat COVID-19 Infection
Primary Purpose
COVID, Covid-19, Corona Virus Infection
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ivermectin
Doxycycline Hcl
Zinc
Vitamin D3
Vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- Healthy male or female subjects at least 18 years of age
- Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
- Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
- Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
- Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.
Exclusion Criteria:
- Refusal to sign informed consent form
- Negative test for COVID-19 by RT-PCR at screening
- Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
- Known drug allergy to any of the investigational medications
- Currently taking medication with known drug interactions with investigational medications, found in Appendix II
- Prescription or other antiviral medications
- Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
- Inability to attend daily for 10 days
Sites / Locations
- ProgenaBiome
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Arm
Placebo
Arm Description
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Placebo and Vitamin D3, Vitamin C, and Zinc
Outcomes
Primary Outcome Measures
Time to Non-Infectivity by RT-PCR
Time to negative RT-PRC result indicating that patient is no longer infective
Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Efficacy of Treatment as measured by Titer
Patients will have serum stored for titer testing to compare antibody levels over time
Efficacy of Treatment as measured by RT-PCR
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Secondary Outcome Measures
Safety of Treatment as Measured by D-Dimer
Blood D-Dimer levels
Safety of Treatment as Measured by Pro-Calcitonin
Blood Pro-Calcitonin levels
Safety of Treatment as Measured by C-Reactive Protein
Blood CRP levels
Safety of Treatment as Measured by Ferritin
Blood ferritin levels
Safety of Treatment as Measured by Liver Enzymes
Blood enzyme levels
Safety of Treatment as Measured by Complete Blood Count
CBC
Safety of Treatment as Measured by Electrolyte Levels
Blood electrolytes
Safety of Treatment as Measured by Treatment Related Adverse Events
Presence or absence of Grade 3 or high treatment related adverse events
Full Information
NCT ID
NCT04482686
First Posted
July 21, 2020
Last Updated
October 26, 2021
Sponsor
ProgenaBiome
Collaborators
Topelia Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT04482686
Brief Title
Trial of Combination Therapy to Treat COVID-19 Infection
Official Title
A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProgenaBiome
Collaborators
Topelia Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Detailed Description
Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Covid-19, Corona Virus Infection, Coronavirus Infection, Coronavirus-19, SARS-CoV2, SARS-CoV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Arm
Arm Type
Experimental
Arm Description
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo and Vitamin D3, Vitamin C, and Zinc
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Soolantra, Stromectol, Sklice
Intervention Description
Treatment days 1, 4, and 8
Intervention Type
Drug
Intervention Name(s)
Doxycycline Hcl
Other Intervention Name(s)
Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory
Intervention Description
10 day treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Other Intervention Name(s)
Zinc sulphate
Intervention Description
10 Day treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol-D3
Intervention Description
10 day treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
L-ascorbic acid
Intervention Description
10 day treatment
Primary Outcome Measure Information:
Title
Time to Non-Infectivity by RT-PCR
Description
Time to negative RT-PRC result indicating that patient is no longer infective
Time Frame
6 months
Title
Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
Description
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time Frame
6 months
Title
Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
Description
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time Frame
6 months
Title
Efficacy of Treatment as measured by Titer
Description
Patients will have serum stored for titer testing to compare antibody levels over time
Time Frame
6 months
Title
Efficacy of Treatment as measured by RT-PCR
Description
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Safety of Treatment as Measured by D-Dimer
Description
Blood D-Dimer levels
Time Frame
6 Months
Title
Safety of Treatment as Measured by Pro-Calcitonin
Description
Blood Pro-Calcitonin levels
Time Frame
6 Months
Title
Safety of Treatment as Measured by C-Reactive Protein
Description
Blood CRP levels
Time Frame
6 Months
Title
Safety of Treatment as Measured by Ferritin
Description
Blood ferritin levels
Time Frame
6 Months
Title
Safety of Treatment as Measured by Liver Enzymes
Description
Blood enzyme levels
Time Frame
6 Months
Title
Safety of Treatment as Measured by Complete Blood Count
Description
CBC
Time Frame
6 Months
Title
Safety of Treatment as Measured by Electrolyte Levels
Description
Blood electrolytes
Time Frame
6 Months
Title
Safety of Treatment as Measured by Treatment Related Adverse Events
Description
Presence or absence of Grade 3 or high treatment related adverse events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
Healthy male or female subjects at least 18 years of age
Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.
Exclusion Criteria:
Refusal to sign informed consent form
Negative test for COVID-19 by RT-PCR at screening
Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
Known drug allergy to any of the investigational medications
Currently taking medication with known drug interactions with investigational medications, found in Appendix II
Prescription or other antiviral medications
Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
Inability to attend daily for 10 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Organizational Affiliation
ProgenaBiome
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Borody, MD
Organizational Affiliation
Topelia Therpeutics
Official's Role
Study Director
Facility Information:
Facility Name
ProgenaBiome
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35135310
Citation
Hazan S, Dave S, Gunaratne AW, Dolai S, Clancy RL, McCullough PA, Borody TJ. Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patients. Future Microbiol. 2022 Mar;17:339-350. doi: 10.2217/fmb-2022-0014. Epub 2022 Feb 9. Erratum In: Future Microbiol. 2022 Sep;17:1091.
Results Reference
derived
Learn more about this trial
Trial of Combination Therapy to Treat COVID-19 Infection
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