Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
estimated completion

Description

Summary

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

Details

Effective therapies for COVID-19 are urgently needed. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggest potential efficacy in small human studies. Clinical trial data are needed to determine whether hydroxychloroquine is effective in treating COVID-19.

Study Aim: To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Study Hypothesis: Among adults hospitalized with COVID-19, administration of hydroxychloroquine will improve clinical outcomes at Day 15.

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Keywords

Coronavirus Acute Respiratory Infection SARS-CoV Infection COVID-19 Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Hydroxychloroquine Hydroxychlorquine

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥18 years
  2. Currently hospitalized or in an emergency department with anticipated hospitalization.
  3. Symptoms of acute respiratory infection, defined as one or more of the following:
  4. cough
  5. fever (> 37.5° C / 99.5° F)
  6. shortness of breath
  7. sore throat
  8. Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.

You CAN'T join if...

  1. Prisoner
  2. Pregnancy
  3. Breast feeding
  4. Symptoms of acute respiratory infection for >10 days before randomization
  5. >48 hours between meeting inclusion criteria and randomization
  6. Seizure disorder
  7. Porphyria cutanea tarda
  8. Diagnosis of Long QT syndrome
  9. QTc >500 ms on electrocardiogram within 72 hours prior to enrollment
  10. . Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
  11. . Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
  12. . Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
  13. . Inability to receive enteral medications
  14. . Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
  15. . Previous enrollment in this trial
  16. . The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient

Locations

  • UCSF Fresno not yet accepting patients
    Fresno California 93701 United States
  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
Links
Website for the PETAL Network
ID
NCT04332991
Phase
Phase 3
Study Type
Interventional
Last Updated