The current study is aimed to investigate and compare potential effects of different doses of enoxaparin treatment in patients with severe COVID-19.
Design
Two arm parallel group superiority trial, non-blinded, phase 3. Patients were block randomized in a 1:1 ratio using SPSS software.
Settings and conduct
Severe Covid-19 patients were treated with the respective doses (based on allocated groups) of enoxaparin until discharge or death. Participants and investigators were not blinded.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with an RT-PCR confirmed COVID-19 diagnosis and severe clinical presentations who required hospitalization were eligible for inclusion if they had D-dimer levels of more than four times the normal upper limit. Severe COVID-19 presentation was defined as the presence of two of the following: (1) respiratory rate over 30 times/minute, (2) Spo2 of less than 93%, (3) Pao2/Fio2 less than 300 mmHg, (4) rapid progression (>50%) on CT-scan over 24-48 hours (10).
Exclusion criteria included pregnancy, history of CVA in the last month, history of major surgery in the last two weeks, history of heparin-induced thrombocytopenia, other definitive indications for therapeutic anti-coagulant treatment, and definitive enoxaparin contraindications.
Intervention groups
Intervention group: Enoxaparin with therapeutic dose
Control group: Enoxaparin with prophylactic dose
Main outcome variables
All case mortality and overall survival
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220412054515N1
Registration date:2022-05-04, 1401/02/14
Registration timing:prospective
Last update:2022-05-04, 1401/02/14
Update count:0
Registration date
2022-05-04, 1401/02/14
Registrant information
Name
Mohamadreza Fattahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 4517
Email address
mr-fattahi@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-08-30, 1401/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of enoxaparin effects with prophylactic or therapeutic dosage on overall survival in severe COVID-19 patients
Public title
Prophylactic vs. therapeutic enoxaparin in severe COVID-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 infection diagnosed by PCR
Hospitalization requirement
Having at least two signs of severe COVID-19 infection: (1) respiratory rate>30 (2) Spo2<93% (3) Pao2/Fio2<300 (4) progression in CT scan imaging>50% in 48 hours
Exclusion criteria:
Pregnancy
History of CVA in last month
History of major surgery in last two weeks
History of heparin induced thrombocytopenia
Other definitive indications for therapeutic enoxaparin treatment
Any contraindication for enoxaparin treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
220
Randomization (investigator's opinion)
Randomized
Randomization description
Individual patients were randomized in a 1:1 ratio, using block randomization with a computer-generated random allocation algorithm. allocations were concealed until randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Sina Hospital
Street address
Sina Hospital, Hassan-Abad square, Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2022-05-01, 1401/02/11
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.013
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Cumulative 6-month survival
Timepoint
6 months after admission
Method of measurement
Visit or phonecall
Secondary outcomes
1
Description
Hospitalization duration (days)
Timepoint
After discharge or death
Method of measurement
Patient files
2
Description
Need for Intensive Care Unit admission
Timepoint
After discharge or death
Method of measurement
Patient files
3
Description
Need for mechanical ventilation
Timepoint
After discharge or death of patient
Method of measurement
Patient files
4
Description
Major bleeding defined by International Society on Thrombosis and Haemostasis criteria
Timepoint
After discharge or death
Method of measurement
Patient files
Intervention groups
1
Description
Intervention group: Therapeutic dose enoxaparin group: subcutaneous injections of enoxaparin, 1 mg/Kg, Twice a day, Tehran Chemie Co., if patients had a GFR lower than 30 mL/min injections were administered only once a day
Category
Treatment - Drugs
2
Description
Control group: Prophylactic dose enoxaparin group: subcutaneous injections of enoxaparin, 40 mg, once a day, Tehran Chemie Co., if patients had a GFR lower than 30 mL/min, 30 mg dose was used, in cases of a BMI greater than 40 injections were administered twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammadreza Fattahi
Street address
Sina Hospital, Imam-Khomeini street, Hassan-Abad square