Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial

COVID-19 Clinical Trial

Official title:

Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04382625
• Other study ID #: 18244
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2020
• Source: Kootenai Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Novel coronavirus SARS(Severe Acute Respiratory Syndrome)-CoV-2 was first identified during the outbreak in Wuhan, China in December 2019 with the now resulting pandemic. Aggressive supportive care is the mainstay of treatment currently and rescue with lung protective mechanical ventilation is essential for survival in patients with severe acute respiratory distress syndrome. Despite supportive care, mortality is significant in hospitalized patients in the U.S., especially among patients > 65 years of age. Pharmacologic treatments to decrease disease severity are urgently needed. Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria. In vitro and in vivo antiviral activity towards SARS-CoV-2 has been reported. Since hydroxychloroquine has been used for decades its properties as a drug are well known. The investigators propose a pragmatic trial of hydroxychloroquine in moderately ill hospitalized adults with SARS-CoV-2 pneumonia with the hypothesis that hydroxychloroquine reduces severity of acute lung injury caused by SARS-CoV-2 infection.

Description:

Novel coronavirus SARS-CoV-2 was first identified during the outbreak in Wuhan, China in December 2019 with the now resulting pandemic. Aggressive supportive care is the mainstay of treatment currently and rescue with lung protective mechanical ventilation is essential for survival in patients with severe acute respiratory distress syndrome. Despite supportive care, mortality is significant in hospitalized patients in the U.S., especially among patients > 65 years of age. Pharmacologic treatments to decrease disease severity are urgently needed. Candidate treatments with antiviral activity and/or immune-modulating effects include hydroxychloroquine (HCQ), lopinavir/ritonavir, remdesivir, and tocilizumab among others. There is limited high quality clinical data prompting a dilemma of how to use and review potential treatments and ensure patient safety now as the pandemic begins to peak. There are also significant limitations in drug supplies at many institutions.

Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria. In vitro and in vivo antiviral activity towards SARS-CoV-2 has been reported. Since hydroxychloroquine has been used for decades its properties as a drug are well known. Pertinent adverse events to monitor in a hospitalized patient include QTc (corrected QT interval) prolongation, elevation of liver enzymes/acute liver injury, and hypokalemia.

Acute lung injury and progressive respiratory failure is the major cause of mortality in SARS-CoV-2 infection. In acute lung injury and respiratory distress syndrome, the severity of hypoxia is categorized by the Pao2/FIO2 (fraction of inspired oxygen) ration as mild (200 mm Hg

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years of age

2. SARS-CoV-2 positive per FDA approved RT-PCR (reverse transcription-polymerase chain reaction)

3. Acute hypoxia (O2 sat < 90 % or paO2 < 60 on room air), or above baseline chronic O2 requirement

4. Inpatient admission

Exclusion Criteria:

1. Requires supplemental O2 >10 litres per minute or mechanical ventilation on admission

2. Pregnancy

3. AST/ALT > 5 times the upper limit normal

4. Baseline prolonged QT

5. Child-Pugh Score B or greater

6. ESRD(end-stage renal disease) requiring dialysis

7. Known allergy to medication component,

8. History of severe G6PD (glucose-6-phosphate dehydrogenase)

9. Myasthenia gravis

10. Porphyria

11. Ongoing treatment for epilepsy

12. Life expectancy < 6 months,

13. Patient lacks capacity to provide consent and does not have a surrogate decision maker.

14. Retinal Disease

Related Conditions & MeSH terms

• COVID-19
• Pneumonia
• SARS-CoV-2 Pneumonia

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria.

Locations

Country	Name	City	State
United States	Kootenai Health	Coeur d'Alene	Idaho

Sponsors (2)

Lead Sponsor	Collaborator
Kootenai Health	Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Oxygenation on Day 1 to Day 5	paO2	Day 1 of treatment to day 5 of treatment
Primary	Change from Baseline Oxygenation at Day 5	FIO2	Day 1 of treatment to day 5 of treatment
Secondary	Intensive Care length of stay	Length in hours	Day 0 to Day 28
Secondary	Required Mechanical Ventilation	Length in hours	Day 0 to Day 28
Secondary	Required Oxygen supplementation	Length in hours	Day 0 to Day 28
Secondary	Hospitalization length of Stay	Length in hours	Day 0 to Day 28
Secondary	Mortality	Date of Death	Day 0 to Day 28
Secondary	Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia	Cardiologist Diagnostic Documentation	Day 0 to Day 28
Secondary	Cardiac Arrhythmia - Ventricular Tachycardia	Cardiologist Diagnostic Documentation	Day 0 to Day 28
Secondary	Cardiac Arrhythmia - Lengthening QTc	Cardiologist Diagnostic Documentation	Day 0 to Day 28