Clinical trial: Tafenoquine in Patients With Mild to Moderate COVID-19 (NCT04533347)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female, aged ≥18 years of age;

          -  Laboratory confirmed infection with COVID-19 virus by an FDA-authorized SARS-Cov-2
             RT-PCR;

          -  Able and willing to give written informed consent.

          -  Willing to keep an electronic diary from Study Day 1 to Study Day 13 (± 1 day) and
             Study Day 15 (± 1 day) to Study Day 28 (± 1 day)

          -  Willing to have daily phone or videoconferences with study team personnel from Study
             Day 1 to Day 13 (± 1 day) and Day 28

          -  At least one of the following clinical symptoms of COVID-19 infection within the 4
             days prior to and inclusive of the day of screening:

               1. Respiratory rate ≥ 24/min

               2. New cough or shortness of breath that has presented within the last 4 days

               3. Fever - temperature 37.7°C [oral or skin surface]

          -  Must agree not to enroll in another study of an investigational agent prior to
             completion of Day 28 of the study.

          -  Able to take ARAKODA or KODATEF according to Prescribing Information

          -  Have been symptomatic no longer than 5 days when the first dose of study medication is
             administered.

          -  If female, agree to use an acceptable method of birth control from the time of consent
             through 56 days after the last dose of study drug.

        Exclusion Criteria:

          -  Have one of the contraindications for ARAKODA or KODATEF in the prescribing
             information (section 16.1) including:

               1. G6PD deficiency

               2. Breastfeeding

               3. Psychotic disorder or current psychotic symptoms

               4. Known hypersensitivity reaction to TQ

          -  Evidence of severe or critical illness, defined by at least one of the following:

               1. Clinical signs indicative of severe systemic illness with COVID-19, such as
                  respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2
                  ≤93% on room air

               2. Respiratory failure defined based on resource utilization requiring at least one
                  of the following:

             i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow
             nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at
             flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive
             pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical
             diagnosis of respiratory failure (i.e., clinical need for one of the preceding
             therapies, but preceding therapies not able to be administered in setting of resource
             limitation) ii. Shock (defined by systolic blood pressure < 90 mmHg, or diastolic
             blood pressure <60 mmHg or requiring vasopressors) iii. Multi-organ
             dysfunction/failure

          -  Any other clinically significant acute illness unrelated to COVID-19 within seven days
             prior to first study drug administration

          -  Receipt of any experimental treatment for COVID-19 (off-label, compassionate use, or
             study-related) within the 30 days prior to the time of the screening evaluation

          -  Any excluded concomitant medication as described in the ARAKODA package insert
             [Section 16.1]

          -  Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of
             possible requirement to hospitalize within 48 hours of enrollment

          -  Positive pregnancy test

          -  Have been symptomatic for more than five days when the first dose would be
             administered
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.


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