Use of Desferal for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection
Primary Purpose
Covid 19
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Desferal 500 MG Injection
Sponsored by
About this trial
This is an interventional treatment trial for Covid 19
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Desferal
control group
Arm Description
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
Will receive glucose 5% over 4 hrs infusion
Outcomes
Primary Outcome Measures
Mortality rate
patient dies from ARDS
Secondary Outcome Measures
Duration of severe symptoms
time to recovery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04389801
Brief Title
Use of Desferal for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection
Official Title
The Use of Desferal and Adjuvants for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hesham Al-Inany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Placebo group Will receive glucose 5% over 4 hrs infusion
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desferal
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Will receive glucose 5% over 4 hrs infusion
Intervention Type
Drug
Intervention Name(s)
Desferal 500 MG Injection
Intervention Description
iron chelating agent
Primary Outcome Measure Information:
Title
Mortality rate
Description
patient dies from ARDS
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Duration of severe symptoms
Description
time to recovery
Time Frame
two weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
email
IPD Sharing Time Frame
five years
IPD Sharing Access Criteria
electronic
IPD Sharing URL
http://www.cu.edu.eg
Learn more about this trial
Use of Desferal for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection
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