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Trial - NCT04400929


Column Value
Trial registration number NCT04400929
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04400929

First author
Last imported at : May 12, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

Jenny Low

Contact
Last imported at : May 12, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-26

Recruitment status
Last imported at : May 12, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - sars-cov-2 pcr-confirmed covid-19 infection - presence of acute hypoxic respiratory failure defined as (either or both) - saturation < 94% on room air or requiring supplemental oxygen - pao2/fio2 below 350 - age 21-80 - able and willing to provide informed consent

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- patients who are already on supplemental oxygen of fio2 ≥ 0.4 - patients with known history of serious allergic reactions, including anaphylaxis, to human gm-csf such as leukine®, yeast-derived products, or any component of the product. - mechanical ventilation before start of study - patients enrolled in another investigational drug study - pregnant or breastfeeding females (all female subjects of childbearing potential status must have negative pregnancy test at screening) - patients with peripheral white blood cell count above 25,000 per microliter and/or active myeloid malignancy - patients on high dose systemic steroids (> 20mg methylprednisolone or equivalent) - patients on lithium carbonate therapy - patients with serum ferritin >2000 mcg/ml (which will exclude ongoing hlh)

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Singapore General Hospital

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

21

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Singapore

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : May 12, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

2

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Measuring oxygenation

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1147, "treatment_name": "Sargramostim", "treatment_type": "Csf", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]