Study: NCT04341441

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydroxychloroquine - Daily Dosing
Description: The daily hydroxychloroquine treatment arm will receive a 200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.~All treatment groups will receive placebo pills to have the patients take 2 pills a day.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydroxychloroquine - Weekly Dosing
Description: The once weekly randomized treatment arm will receive the proposed dose of hydroxychloroquine for prophylaxis of malaria is 6.5 mg/kg per dose (maximum of 400 mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria~All treatment groups will receive placebo pills to have the patients take 2 pills a day.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo oral tablet
Description: Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day..~Participants will receive a monitoring phone call at 4 weeks post study entry to monitor for COVID-19 symptoms and medication side effects. At week 8, participants will provide additional samples of whole blood.~Additional studies will include serology, inflammatory and other disease associated markers. Clinical data and location of main work area will be collected.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Baseline
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Baseline
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Baseline
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Baseline
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 4
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 4
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 4
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 4
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 8
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 8
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 8
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Monitoring Visit - Week 8
Description: Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Weekly Assessment
Description: Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 \&7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Weekly Assessment
Description: Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 \&7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Weekly Assessment
Description: Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 \&7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Weekly Assessment
Description: Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 \&7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.