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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; SARS-CoV-2; ARDS
• Intervention / Treatment: Drug: Dapsone 100 MG

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kanwar; Phone Number: 4694228931; Email: bkanwar2@yahoo.com

Study Locations

• United States
  • Texas
    • Greenville, Texas, United States, 75401
      • Recruiting
      • Hunt Regional Medical Center
      • Contact: Badar Kanwar; Phone Number: 469-422-8931; Email: BKANWAR2@YAHOO.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All, PCR confirmed cases of COVID-19

Exclusion Criteria:

1. Only consenting consenting patients

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Intervention	Drug: Dapsone 100 MG; Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment	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	1 year

Collaborators and Investigators

• Sponsor: Hunt Regional Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (ACTUAL): June 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone
• Other Study ID Numbers: Badar Kanwar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No