An Early Phase 1 interventional study of Dapsone 100 MG in SARS-CoV-2, Hypoxia and ARDS, sponsored by Hunt Regional Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by Hunt Regional Medical Center · Early Phase 1, Interventional, and Treatment
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.
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →This is the only study on the registry with Hunt Regional Medical Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Drug: Dapsone 100 MG
Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID
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
Time frame: 1 year
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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