Title
A Study of Combination Therapies to Treat COVID-19 Infection
A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection
Phase
Phase 2Lead Sponsor
ProgenaBiomeStudy Type
InterventionalStatus
WithdrawnIntervention/Treatment
hydroxychloroquine Azithromycin Ritonavir LopinavirStudy Participants
0This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
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
Treatment with the drug lopinavir
Dual Therapy utilizing hydroxychloroquine and azithromycin.
Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
Inclusion Criteria: 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 Criteria: 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
