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

NCT04389801 | Unknown Phase 4 DMC

• 1 other identifier: 0012
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Covid 19

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  patient dies from ARDS

  two weeks

Secondary Outcomes (1)

• Duration of severe symptoms

  two weeks

Study Arms (2)

Desferal

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

Will receive glucose 5% over 4 hrs infusion

Drug: Desferal 500 MG Injection

Interventions

Desferal 500 MG Injection DRUG

iron chelating agent

Desferal; control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hesham Al-Inany: lead

MeSH Terms

Conditions

COVID-19

Interventions

Deferoxamine; Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo group Will receive glucose 5% over 4 hrs infusion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 15, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: five years
• Access Criteria: electronic