Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease

Study Overview
=================
Brief Summary
-----------------
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

Detailed Description
-----------------
This is a phase 3 study. Primary Objective: • To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial. Secondary Objectives: To evaluate quantitative viral load over time To evaluate length of hospital stay and days in ICU To evaluate toxicity of the treatment options To evaluate rate of readmission after hospital discharge To evaluate duration of clinical symptoms Arm A: Control Arm - Supportive Care Only Arm B: Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5 Arm C: Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5

Official Title
-----------------
Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Positive SARS-CoV-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (PUIs). Onset of symptoms < 7 days from date of enrollment Oxygen saturation of >94% on room air with defined risk factors (Table 1) consistent with moderate disease OR oxygen saturation of < 94% on room air consistent with severe disease Ability and willingness to comply with study procedures Exclusion Criteria: QTc greater than 450 milliseconds on screening EKG Pregnant or lactating women Inability to take oral pills or inability to use a feeding tube Inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. For the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals. Patients requiring ICU level care use of azithromycin or hydroxychloroquine within 30 days prior to admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A<br>Supportive Care only | |
| Experimental: Arm B<br>Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5 | Drug: Hydroxychloroquine<br>* tablets provided as described in Arm B<br>|
| Experimental: Arm C<br>Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5 | Drug: Hydroxychloroquine<br>* tablets provided as described in Arm B<br>Drug: Azithromycin<br>* tablets provided as described in Arm C<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most severe outcome | ordinal outcome of most severe a patient experienced after inpatient admission | 5 days |