Clinical trial NCT04482686: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID
Covid-19
Corona Virus Infection
Coronavirus Infection
Coronavirus-19
SARS-CoV2
SARS-CoV Infection
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
2. Healthy male or female subjects at least 18 years of age
3. Diabetic and obese (BMI \> 30) patients will be included in the Trial but randomization will be stratified.
4. Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
5. 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)
6. 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:

1. Refusal to sign informed consent form
2. Negative test for COVID-19 by RT-PCR at screening
3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature \> 104.0 degrees F, pleuritic pain, or frequent cough.
4. Known drug allergy to any of the investigational medications
5. Currently taking medication with known drug interactions with investigational medications, found in Appendix II
6. Prescription or other antiviral medications
7. Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
8. Inability to attend daily for 10 days

Primary outcomes:
measure: Time to Non-Infectivity by RT-PCR
timeFrame: 6 months
measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
timeFrame: 6 months
measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
timeFrame: 6 months
measure: Efficacy of Treatment as measured by Titer
timeFrame: 6 months
measure: Efficacy of Treatment as measured by RT-PCR
timeFrame: 10 days
Secondary outcomes:
measure: Safety of Treatment as Measured by D-Dimer
timeFrame: 6 Months
measure: Safety of Treatment as Measured by Pro-Calcitonin
timeFrame: 6 Months
measure: Safety of Treatment as Measured by C-Reactive Protein
timeFrame: 6 Months
measure: Safety of Treatment as Measured by Ferritin
timeFrame: 6 Months
measure: Safety of Treatment as Measured by Liver Enzymes
timeFrame: 6 Months
measure: Safety of Treatment as Measured by Complete Blood Count
timeFrame: 6 Months
measure: Safety of Treatment as Measured by Electrolyte Levels
timeFrame: 6 Months
measure: Safety of Treatment as Measured by Treatment Related Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: STUDY_DIRECTOR
affiliation: Topelia Therpeutics
name: Thomas Borody, MD
role: STUDY_DIRECTOR
References:
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.