Trial of Combination Therapy to Treat COVID-19 Infection

Phase 1

• Conditions: COVID; Covid-19; Corona Virus Infection; Coronavirus Infection; Coronavirus-19; SARS-CoV2; SARS-CoV Infection
• Interventions: Drug: Ivermectin; Drug: Doxycycline Hcl; Dietary Supplement: Zinc; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin C

• Registration Number: NCT04482686
• Lead Sponsor: ProgenaBiome

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Study Start: 2020-12-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-02
• Primary Completion: 2022-05
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Arm	Doxycycline Hcl	Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Active Arm	Zinc	Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Active Arm	Vitamin D3	Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Active Arm	Vitamin C	Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Placebo	Zinc	Placebo and Vitamin D3, Vitamin C, and Zinc
Placebo	Vitamin D3	Placebo and Vitamin D3, Vitamin C, and Zinc
Placebo	Vitamin C	Placebo and Vitamin D3, Vitamin C, and Zinc
Active Arm	Ivermectin	Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C

Primary Outcome Measures

Name	Time	Method
Time to Non-Infectivity by RT-PCR	6 months	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)	6 months	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)	6 months	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	6 months	Patients will have serum stored for titer testing to compare antibody levels over time
Efficacy of Treatment as measured by RT-PCR	10 days	Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment

Secondary Outcome Measures

Name	Time	Method
Safety of Treatment as Measured by D-Dimer	6 Months	Blood D-Dimer levels
Safety of Treatment as Measured by Pro-Calcitonin	6 Months	Blood Pro-Calcitonin levels
Safety of Treatment as Measured by C-Reactive Protein	6 Months	Blood CRP levels
Safety of Treatment as Measured by Ferritin	6 Months	Blood ferritin levels
Safety of Treatment as Measured by Liver Enzymes	6 Months	Blood enzyme levels
Safety of Treatment as Measured by Complete Blood Count	6 Months	CBC
Safety of Treatment as Measured by Electrolyte Levels	6 Months	Blood electrolytes
Safety of Treatment as Measured by Treatment Related Adverse Events	6 months	Presence or absence of Grade 3 or high treatment related adverse events

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States