Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk

NCT04371926 | Withdrawn

• 1 other identifier: TCAI_PREVENT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Time to reach normal body temperature

  Time to reach normal body temperature (TNBT), ≤37.50 C

  1 month

• Development of COVID-19 symptoms during HCQ preventive therapy in staff

  Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy

  1 month

Secondary Outcomes (2)

• COVID-19 test result at follow-up in patients

  6 days

• Worsening of symptoms in COVID-19 patients

  1 month

Study Arms (2)

HCQ arm

ACTIVE COMPARATOR

COVID-19 positive cases will receive receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff randomized to this group will receive HCQ sulfate 400 mg/week for 4 weeks

Drug: Hydroxychloroquine Sulfate

No-HCQ arm

NO INTERVENTION

Will receive standard treatment as needed, but no HCQ

Interventions

Hydroxychloroquine Sulfate DRUG

Patients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff will receive HCQ sulfate 400mg/week for 4 weeks

HCQ arm

Eligibility Criteria

• Age: 18 Months - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female over 18 years of age at the time of enrollment
• COVID-19 test positive patients with mild-moderate symptoms including fever \>37.50 F
• Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19

You may not qualify if:

• Hepatic cirrhosis or active hepatitis B or C
• Severe renal disease
• Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO
• Contraindication to HCQ
• Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis)
• Pregnant or breast feeding
• Known history of long QT syndrome (QTc \>500 ms on electrocardiogram)
• Seizure disorder
• Body weight \<50kg
• Psoriasis
• Unwilling to provide informed consent

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrea Natale, MD

  St. David's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Model Details: Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group. Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-04