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Column | Value |
---|---|
Trial registration number | NCT05255848 |
Full text link
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
m.imran@lrh.edu.pk |
Registration date
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
2022-02-25 |
Recruitment status
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not recruiting |
Study design
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Single group assignment |
Masking
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age 18 year or older. either gender currently admitted to hospital. there is a pcr-positive sample for sars-cov-2 within the past 21 days. the sample can be a nasal or pharyngeal swab, sputum, tracheal aspirate, broncho alveolar lavage, or another sample from the patient who modified ordinal clinical scale 3-5 |
Exclusion criteria
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
intubated and on mechanical ventilation, or requiring immediate intubation as per the treating clinician's assessment heparin allergy or heparin-induced thrombocytopenia aptt >120 s, not due to anticoagulant therapy and does not correct with the administration of fresh frozen plasma platelet count <20 × 109 /l pulmonary bleeding or uncontrolled bleeding pregnant or might be pregnant acute brain injury that may result in long-term disability myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. guillain-barre syndrome treatment limitations in place (ceiling of care), i.e. not for intubation, not for icu admission death is imminent or inevitable within 24 h clinician objection refusal to consent |
Number of arms
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Lady Reading Hospital, Pakistan |
Inclusion age min
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Pakistan |
Type of patients
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
180 |
primary outcome
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Number of patients requiring Intubation |
Notes
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
Arms
Last imported at : Feb. 26, 2022, 7 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |