A Study of Combination Therapies to Treat COVID-19 Infection
Withdrawn before enrolling · Phase 2
Conditions studied: COVID, COVID-19, Corona Virus Infection, Coronavirus Infection, Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere, Coronavirus-19, SARS-CoV 2, SARS Pneumonia
In brief
This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
Key facts
- Study ID
- NCT04459702
- Run by
- ProgenaBiome
- People needed
- 0
- Starts
- 2020-07-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-04-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- ProgenaBiome — Ventura, California, United States
Full record on ClinicalTrials.gov
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