NCT04918914

Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment

Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hunt Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Abstract Background: Clinicians in pulmonary critical care medicine and critical care medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3 (NLRP3). Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3 inflammasome by dapsone must be responsible for its observed preventive effects, functioning as a competitor. Methods: Patients who were on standard COVID-19 therapy are also after obtaining off label uses and explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400 mg three times daily.

Detailed description

We are investigating in prospective ongoing non-randomized case study effects of addition of dapsone 100-200 mg daily in addition to standardized recommended treatment versus a a cohort of patient admitted at our institution since October 2020 versus a group that only received standardized treatment. Our primary out comes are decrease in FIO2 requirement leading to discharge from hospital and decrease in over all mortality between group treated with only standardized recommended treat versus group with addition of dapsone and cimetadine. An objective criteria of improvement, was used for effectiveness of therapy. A. a reduction in the FIO2 requirement and B. a decrease in the progression of hypoxia. We treated the patients with standard COVID-19 ARDS treatment with dapsone 100 mg to target NLRP3 inflammasomes.

Conditions

• SARS-CoV-2
• Hypoxia
• ARDS

Interventions

Type	Name	Description
DRUG	Dapsone 100 MG	Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID

Timeline

• Start date: 2020-10-18
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study