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

Covid 19 Clinical Trial

Official title:

The Use of Desferal and Adjuvants for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04389801
• Other study ID #: 0012
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Covid 19
• Infection

Intervention

Drug:
• Desferal 500 MG Injection
iron chelating agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hesham Al-Inany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	patient dies from ARDS	two weeks
Secondary	Duration of severe symptoms	time to recovery	two weeks