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Use of Desferal for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection

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ClinicalTrials.gov Identifier: NCT04389801
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Hesham Al-Inany, Cairo University

Brief Summary:
To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images

Condition or disease Intervention/treatment Phase
Covid 19 Drug: Desferal 500 MG Injection Phase 4

Detailed Description:

COVID-19 is a condition caused by a coronavirus (called SARS-CoV-2) that was first identified in late 2019. In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. Recent theory showed that the severe respiratory manifestations could be due to iron toxicity which cause intense inflammation in the alveoli and hence the ground glass appearance that was seen in ragdiology imaging

Objective :

To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images

Randomisation:

Participants are randomly allocated to either standard care or standard care plus Desferal injection. Randomization will be done through computer generated list by principal investigator. Allocation will be determined by block randomisation, stratified by hospital. This will be carried out by an independent statistician, prior to the trial commencement, using Stata (StataCorp, College Station, TX, USA) to generate the allocation sequence. Allocations will be concealed within sequentially numbered, sealed opaque envelopes, prepared by two research assistants who are independent of the trial Blinding This study will be single blind. Doctors will not be blinded to intervention allocation due to lack of feasibility

Sample size:

Two hundred participants randomized into two groups each 100 individuals. The trial will begin as a 1:1 randomised trial Intervention Model Parallel assignment Desferal group An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours. The total amount administered should not exceed 6000 mg in 24 hours

Placebo group Will receive glucose 5% over 4 hrs infusion

Standard care :- including clexan 40, antibiotics, corticosteroids ( as anti-inflammatory agent) and hydroxychloroquine

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Desferal group An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours.
Masking: Single (Participant)
Masking Description: Placebo group Will receive glucose 5% over 4 hrs infusion
Primary Purpose: Treatment
Official Title: The Use of Desferal and Adjuvants for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection: A Randomized Controlled Trial
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Desferal
An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours
Drug: Desferal 500 MG Injection
iron chelating agent

Placebo Comparator: control group
Will receive glucose 5% over 4 hrs infusion
Drug: Desferal 500 MG Injection
iron chelating agent




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: two weeks ]
    patient dies from ARDS


Secondary Outcome Measures :
  1. Duration of severe symptoms [ Time Frame: two weeks ]
    time to recovery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients positive for Covid 19 admitted to hospital with chest tightness

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Known severe hepatic impairment
  • Known severe renal impairment
  • Known porphyrias
  • Diabetes mellitus
  • Known G6PD deficiency
  • Known myasthenia gravis
  • Known severe psoriasis
  • Known severe neurological disorders (especially those with a history of epilepsy — may lower seizure threshold)
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Responsible Party: Hesham Al-Inany, Prof, Cairo University
ClinicalTrials.gov Identifier: NCT04389801    
Other Study ID Numbers: 0012
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: email
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: five years
Access Criteria: electronic
URL: http://www.cu.edu.eg

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Deferoxamine
Siderophores
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action