Status:
WITHDRAWN
A Study of Combination Therapies to Treat COVID-19 Infection
Lead Sponsor:
ProgenaBiome
Collaborating Sponsors:
Big Corona Ltd.
Conditions:
COVID
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
Detailed Description
In this study, patients will be administered either dual or quadruple therapy and have PCR tests run daily to determine efficacy as indicated by time to non-infectivity
Eligibility Criteria
Inclusion
- Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- Healthy, ambulant male or female subjects 18 years of age to 65 years of age
- Positive test for COVID-19 by RT-PCR at screening
- Subjects must agree to practice at least one highly effective method 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. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
- Subjects must agree they will do their best to attend the treatment facility daily for 10 days
Exclusion
- 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 \> 38 degrees; pleuritic pain, or frequent cough.
- Known drug allergy to any of the investigational medications
- Currently taking medication with known drug interactions with investigational medications (listed in appendix)
- Prescription or other antiviral medications
- Any comorbidities which constitute health risk for the subject
- Pregnant or lactating females;
- weight \< 110lb;
- porphyria
- established retinal disease
- Inability to attend daily for 10 days
- 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
- History of QT \>500msec
- History of torsades de pointes
- Anemia from pyruvate kinase and G6PD deficiencies
- Abnormal EKG with QT prolongation acquired or from birth
- History of jaundice or high fevers prior to developing COVID-19
- Treatment with any of the medications listed in Appendix II
- Treatment with any anti-epileptic medication
- Treatment with any other drug not listed that affects the QT interval
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04459702
Start Date
July 1 2020
End Date
December 1 2021
Last Update
April 8 2021
Active Locations (1)
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1
ProgenaBiome
Ventura, California, United States, 93003