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

NCT04918914 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: Badar Kanwar
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; Hypoxia; ARDS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

OTHER

Drug: Dapsone 100 MG

Interventions

Dapsone 100 MG DRUG

Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All, PCR confirmed cases of COVID-19

You may not qualify if:

• \. Only consenting consenting patients

Sponsors & Collaborators

• Hunt Regional Medical Center: lead

Study Sites (1)

Hunt Regional Medical Center

Greenville, Texas, 75401, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals

Central Study Contacts

Kanwar

CONTACT

4694228931; bkanwar2@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Addition of dapsone to COVID19 patient treated with standard treatment

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: October 18, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)