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

Early Phase 1

• Conditions: SARS-CoV-2; Hypoxia; ARDS
• Interventions: Drug: Dapsone 100 MG

• Registration Number: NCT04918914
• Lead Sponsor: Hunt Regional Medical Center

Brief 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.

Study Timeline

• Study Start: 2020-10-18
• Study First Submitted: 2021-05-27
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. All, PCR confirmed cases of COVID-19

Exclusion Criteria

1. Only consenting consenting patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Dapsone 100 MG	-

Primary Outcome Measures

Name	Time	Method
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment	1 year	1. Decrease in overall mortality between groups treated with standardized recommended composite therapy for COVID-19 versus group of Standardized therapy plus addition of dapson and cimedatine

Trial Locations

Locations (1)

Hunt Regional Medical Center; 🇺🇸 Greenville, Texas, United States