SARS-CoV-2Early Phase 1NCT04918914
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
A Early Phase 1 study testing Dapsone 100 MG in people with SARS-CoV-2 and Hypoxia, run by Hunt Regional Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV-2, Hypoxia, ARDS
- What is being tested?
- Dapsone 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2020to 31 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. All, PCR confirmed cases of COVID-19
Who cannot join
- 1. Only consenting consenting patients
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hunt Regional Medical Center
Greenville, Texas, 75401
Badar Kanwar, 469-422-8931, BKANWAR2@YAHOO.COM
About this study
Official title: 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.
Read the 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 reduction in the FIO2 requirement and
- 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
- Being tested
- Dapsone 100 MG
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapsone 100 MGDrug
Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Not described Receives: Drug: Dapsone 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
- 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start18 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Addition of dapsone to COVID19 patient treated with standard treatment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunt Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Badar Kanwar, Hunt Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918914
- Sponsor's protocol ID
- Badar Kanwar
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04918914
- Acronym / sponsor ID
- Badar Kanwar
- Conditions
- SARS-CoV-2, Hypoxia, ARDS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hunt Regional Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 reduction in the FIO2 requirement and
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Addition of dapsone to COVID19 patient treated with standard treatment
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Drug: Dapsone 100 MG |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All, PCR confirmed cases of COVID-19
Key exclusion criteria (2 listed)
- 1. Only consenting consenting patients
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapsone 100 MGDapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID | Drug | Intervention |
Primary outcome
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dapsone 100 MG in people with SARS-CoV-2 and Hypoxia, run by Hunt Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kanwar (4694228931, bkanwar2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.