A Phase 4 interventional study of Desferal 500 MG Injection in Covid 19, sponsored by Hesham Al-Inany. Status unknown. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Hesham Al-Inany · Phase 4, Interventional, and Treatment
To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Hesham Al-Inany as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Will receive glucose 5% over 4 hrs infusion
Drug: Desferal 500 MG Injection
iron chelating agent
Mortality rate
patient dies from ARDS
Time frame: two weeks
Duration of severe symptoms
time to recovery
Time frame: two weeks
No study locations are listed for this record.
Plan to share: Yes — email
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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