v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04334629 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 27, 2023, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : July 27, 2023, 4 a.m. Source : ClinicalTrials.gov |
None |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-06 |
|
Recruitment status
Last imported at : July 27, 2023, 4 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
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 : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: male or female patients aged 18 years and above; hospitalised; confirmed or suspected sars-cov-2 infection; national early warning score (news2) greater than or equal to 3 in a single parameter or news2 > 5 overall; acute hypoxemic respiratory failure: pao2/fio2 ratio less than or equal to 300 or spo2/fio2 ratio < 315 (kigali modification) provision of written informed consent by the patient or by the patient's legal representative or professional consultee. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
any of the following contraindications to ibuprofen: a known hypersensitivity to ibuprofen or any other constituent of the medicinal product; patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (nsaids); patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with nsaids; patients with severe hepatic failure; patients with acute renal failure; patients with severe heart failure. participation in any other investigational drug products less than 30 days prior to study enrolment; glasgow coma score < 12; patients who cannot swallow oral capsules; pregnant or lactating women; any medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial. |
|
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 |
King's College London |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United Kingdom |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : July 27, 2023, 4 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Disease progression;Time to mechanical ventilation |
|
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 4 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Justification for missing results available from 2020-001203-16 on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001203-16/results", "treatment_id": 619, "treatment_name": "Ibuprofen", "treatment_type": "Non-steroidal anti-inflammatory", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Justification for missing results available from 2020-001203-16 on https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001203-16/results", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |