PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19

Population A: Symptomatic adults seeking care or testing for COVID-19

Inclusion Criteria

• Age ≥ 18 years
• Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment
• Presence of two or more Screening Symptoms listed in Supplement 3 with at least two symptoms classified as moderate to severe (and/or ≥ 2 on the frequency questions or loss of taste/smell questions) at the time of enrollment a. For participants who have preexisting conditions causing mild or moderate symptoms listed on the Screening Symptom Questionnaire, there must be an increase of at least one severity level for that symptom at enrollment (For example, prior to illness participant routinely experienced headaches rated as moderate severity, now rating headache as severe at enrollment)
• Supplement 3 Screening Symptoms: stuffy or runny nose, hoarse voice, sore throat, difficulty breathing, cough, fatigue (low energy or tiredness), muscle or body aches, headache, fever (documented temperature > 38° C [100.4° F]) or subjective fever, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, loss of smell, loss of taste
• Symptom onset ≤ 5 days prior to enrollment

Exclusion Criteria

• Hospital admission at the time of enrollment
• Hospitalization will be defined as requiring medical care not available in an outpatient setting for greater than 24 hours
• Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion
• Laboratory confirmed SARS-CoV-2 infection 6 to 90 days prior to enrollment
• Oxygen saturation 95th percentile in adolescents) iv) Type 1 or type 2 diabetes mellitus v) Cardiovascular disease (including HTN if age >55) vi) Chronic lung disease (including bronchiectasis, CF, COPD, ILD, PHTN, PE, moderate-to-severe asthma) vii) Chronic kidney disease (eGFR 450 msec
• Pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.4-0.5 mV)
• Evidence of ventricular pre-excitation
• Electrocardiographic evidence of complete LBBB, RBBB, incomplete LBBB, in complete RBBB
• Evidence of second- or third-degree heart block
• Intraventricular conduction delay with QRS duration > 120 msec
• Bradycardia as defined by sinus rate< 50 bpm
• Personal or family history of long QT syndrome
• Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, except for sinus arrhythmia
• Syncopal episodes or additional risk factors for torsades de points (e.g., heart failure, hypokalemia)