Status:
COMPLETED
A Study of Quintuple Therapy to Treat COVID-19 Infection
Lead Sponsor:
ProgenaBiome
Collaborating Sponsors:
DSCS CRO
Conditions:
COVID-19
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infect...
Detailed Description
In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.
Eligibility Criteria
Inclusion
- Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- Male or female subjects 18 years of age and up
- Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
- Diagnosis of COVID-19 by RT-PCR
- Exclusion Criteria
- Refusal to provide informed consent
- Diarrhea prior to infection
- Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject
- Any contraindications for treatment with hydroxychloroquine
- Hypoglycemia
- Known G6PD deficiency
- Porphyria
- Anemia
- Neutropenia
- Alcoholism
- Myasthenia gravis
- Skeletal muscle disorders
- Maculopathy
- Changes in visual field
- Liver disease
- Psoriasis
- Anemia from pyruvate kinase and G6PD deficiencies
- Abnormal EKG with QT prolongation acquired or from birth
- Allergies to 4-Aminoquinolines
- History of jaundice or high fevers prior to developing COVID-19
- Treatment with any of the medications listed in Appendix II
- Treatment with any other drug not listed that affects the QT interval
- Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise.
- Pregnant or breastfeeding women
Exclusion
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04334512
Start Date
June 22 2020
End Date
February 27 2024
Last Update
February 29 2024
Active Locations (1)
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1
ProgenaBiome
Ventura, California, United States, 93003