This 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
Drug: hydroxychloroquine
Treatment with the drug hydroxychloroquine
Other Name: Plaquenil
Drug: Azithromycin
Treatment with the drug azithromycin
Other Name: Zithromax
Drug: Ritonavir
Treatment with the drug ritonavir
Other Name: norvir
Drug: Lopinavir
Treatment with the drug lopinavir
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, ambulant male or female subjects 18 years of age to 65 years of age
3. Positive test for COVID-19 by RT-PCR at screening
4. 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)
5. Subjects must agree they will do their best to attend the treatment facility daily for
10 days
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 > 38 degrees; 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 (listed in appendix)
6. Prescription or other antiviral medications
7. Any comorbidities which constitute health risk for the subject
8. Pregnant or lactating females;
9. weight < 110lb;
10. porphyria
11. established retinal disease
12. Inability to attend daily for 10 days
13. Any contraindications for treatment with hydroxychloroquine
1. Hypoglycemia
2. Known G6PD deficiency
3. Porphyria
4. Anemia
5. Neutropenia
6. Alcoholism
7. Myasthenia gravis
8. Skeletal muscle disorders
9. Maculopathy
10. Changes in visual field
11. Liver disease
12. Psoriasis
13. History of QT >500msec
14. History of torsades de pointes
14. Anemia from pyruvate kinase and G6PD deficiencies
15. Abnormal EKG with QT prolongation acquired or from birth
16. History of jaundice or high fevers prior to developing COVID-19
17. Treatment with any of the medications listed in Appendix II
18. Treatment with any anti-epileptic medication
19. Treatment with any other drug not listed that affects the QT interval
ProgenaBiome
Ventura, California, United States