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

NCT ID: NCT04389801

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-12-31

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

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

Conditions

Covid 19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Desferal 500 MG Injection

Intervention Type: DRUG

iron chelating agent

control group

Will receive glucose 5% over 4 hrs infusion

Group Type: PLACEBO_COMPARATOR

Desferal 500 MG Injection

Intervention Type: DRUG

iron chelating agent

Interventions

Desferal 500 MG Injection

iron chelating agent

Intervention Type: DRUG

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hesham Al-Inany

OTHER

Sponsor Role: lead

Responsible Party

Hesham Al-Inany

Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

0012

Identifier Type: -

Identifier Source: org_study_id