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
Drug: Desferal 500 MG Injection
iron chelating agent
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)