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Trial - NCT05255848


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

Muhammad Imran, MBBS, FCPS

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"}]