Trial of Combination Therapy to Treat COVID-19 Infection

Covid-19 Clinical Trial

Official title:

A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04482686
• Other study ID #: PRG-049
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 9, 2020
• Est. completion date: July 2022

Study information

• Verified date: October 2021
• Source: ProgenaBiome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: July 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infection
• Coronavirus Infections
• Coronavirus-19
• COVID
• Covid-19
• Infections
• SARS-CoV Infection
• SARS-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Ivermectin
Treatment days 1, 4, and 8
• Doxycycline Hcl
10 day treatment

Dietary Supplement:
• Zinc
10 Day treatment
• Vitamin D3
10 day treatment
• Vitamin C
10 day treatment

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
ProgenaBiome	Topelia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Non-Infectivity by RT-PCR	Time to negative RT-PRC result indicating that patient is no longer infective	6 months
Primary	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.	6 months
Primary	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.	6 months
Primary	Efficacy of Treatment as measured by Titer	Patients will have serum stored for titer testing to compare antibody levels over time	6 months
Primary	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	10 days
Secondary	Safety of Treatment as Measured by D-Dimer	Blood D-Dimer levels	6 Months
Secondary	Safety of Treatment as Measured by Pro-Calcitonin	Blood Pro-Calcitonin levels	6 Months
Secondary	Safety of Treatment as Measured by C-Reactive Protein	Blood CRP levels	6 Months
Secondary	Safety of Treatment as Measured by Ferritin	Blood ferritin levels	6 Months
Secondary	Safety of Treatment as Measured by Liver Enzymes	Blood enzyme levels	6 Months
Secondary	Safety of Treatment as Measured by Complete Blood Count	CBC	6 Months
Secondary	Safety of Treatment as Measured by Electrolyte Levels	Blood electrolytes	6 Months
Secondary	Safety of Treatment as Measured by Treatment Related Adverse Events	Presence or absence of Grade 3 or high treatment related adverse events	6 months