Clinical trial: COVID-19 Prophylaxis South Africa (COVER HCW) (NCT04561063)

Eligibility criteria:
Inclusion Criteria:

          1. Age ≥18 years of age, inclusive, at the time of signing the informed consent.

          2. Willing and able to provide informed consent via an electronic process.

          3. Healthcare worker employed at a participating institution that has been identified as
             high-risk for SARS-CoV-2 exposure (may include doctors, nurses, nurse aids,
             radiographers, physiotherapists, phlebotomists, technicians, porters, cleaners,
             laboratory or other personnel identified as being at high risk of exposure) or a CHW
             involved in the collection of samples for the identification of SARS-CoV-2 through
             PCR.

          4. 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.

          5. Body weight ≥45 kg.

          6. 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. PCR and/or serology confirmed SARS-Cov-2 infection at screening.

          3. Current symptoms of COVID-19 disease (including, but not limited to, fever or chills,
             cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia,
             or diarrhea).

          4. Self-reported presence or history of any of the following conditions:

               -  Chronic kidney disease (Stage IV or receiving dialysis)

               -  Cirrhosis (Child-Pugh Class B or greater)

               -  Porphyria cutanea tarda.

          5. Currently on treatment for epilepsy or other seizure disorder.

          6. Currently on treatment with a protease inhibitor-based antiretroviral regimen, or
             efavirenz, or on treatment with amiodarone, carbamazepine, phenobarbitone, phenytoin,
             primidone, rifampicin, or St. John's wort.

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

          8. Current enrolment in another COVID-19 prevention trial.

          9. Concurrent or recent (within 3 months) participation in other research with a compound
             likely to interfere with any of the investigational products.

         10. 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.

         11. Inability or unwillingness to be followed up for the study period.

         12. 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. (Personnel employed at a study site, but not directly involved
             in the conduct of the study, who would like to participate in the study, may only do
             so if they are enrolled in the study through a different site at which they are not
             employed.)

         13. 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.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 99 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? Contradiction