Clinical trial: COVID-19 Treatment in South Africa (NCT04532931)

Eligibility criteria:
Inclusion Criteria:

          1. Age from 18 to 65 years of age, inclusive, at the time of signing the informed
             consent.

          2. Willing and able to provide informed consent.

          3. Women of reproductive potential must be using a highly effective method of
             contraception for at least 28 days prior to enrolment and must be able and willing to
             continue its use throughout the duration of the study.

          4. Men must agree to use condoms when engaging in heterosexual sex during the study and
             for the period up to 91 days after the last dose of study medication. Men who are not
             randomized to a treatment arm including favipiravir (or another arm identified as
             having teratogenic potential through semen) will no longer need to adhere to this
             after randomization.

          5. Laboratory confirmed SARS-CoV-2 infection, and any of the following self-reported
             symptoms within 72 hours prior to randomization: fever or chills, cough, myalgia, sore
             throat, shortness of breath, or new onset of anosmia or ageusia.

          6. Body weight ≥45 kg.

          7. Access to reliable video conference, telephone, direct/text messaging, or other device
             permitting real-time, reliable information transfer.

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. Known hypersensitivity or specific contraindications to the use of any of the active
             drugs in the treatment arms, or similar compounds.

          3. Signs of respiratory distress prior to randomization, including:

               -  respiratory rate >24 breaths/min

               -  SpO2 <95% in room air.

          4. Resting pulse rate ≥120 beats/min.

          5. High likelihood of hospitalization in the opinion of the attending clinician.

          6. QTcF >470 msec for females, or >450 msec for males, at screening.

          7. Serum potassium <3.5 mmol/L at screening.

          8. History of clinically significant cardiovascular disease (including arrhythmias,
             QT-interval prolongation, torsades de pointes (TdP), history of coronary artery
             disease with graft or stent procedures/surgery, cardiac failure [class 2 or higher
             using the New York Heart Association functional classification]).

          9. Known chronic kidney disease (Stage IV or receiving dialysis).

         10. Known cirrhosis (Child-Pugh Class B or greater).

         11. Known macular degeneration, or other known retinal diseases, or
             4-aminoquinolone-induced visual impairment.

         12. Currently receiving, or recently received (within 60 days prior to randomization)
             treatment with any of the drugs in the treatment arms.

         13. Currently receiving, or recently received (within 30 days prior to randomization)
             treatment with any antimalarial drugs.

         14. Currently on treatment with drugs with known arrhythmogenic potential, or those known
             to induce significant QT-interval prolongation or TdP, as detailed in Appendix 6.

         15. Currently on treatment for tuberculosis (or on treatment with rifampicin for any other
             indication), or on treatment with a protease inhibitor-based antiretroviral regimen,
             or efavirenz, or carbamazepine.

         16. Inability/unlikely to be in the study area for the duration of the 28 day follow-up
             period.

         17. Any surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of
             the volunteer or the objectives of the study. The Investigator should make this
             determination in consideration of the volunteer's medical history.

         18. Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study
             coordinator or anyone mentioned in the delegation log) directly involved in the
             conduct of the study.

         19. Participant is judged by the Investigator to be at significant risk of failing to
             comply with the provisions of the protocol as to cause harm to self or seriously
             interfere with the validity of the study results.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment