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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05513560 |
|
Full text link
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Feb. 13, 2023, 8:44 a.m. Source : ClinicalTrials.gov |
RECLAIM@uhn.ca |
|
Registration date
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
2022-08-24 |
|
Recruitment status
Last imported at : Oct. 3, 2023, noon Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Oct. 3, 2023, noon Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age ≥18 years; positive covid-19 test by nasopharyngeal swab rt-pcr (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; or presumed covid-19 assessed by the site investigator (no positive covid-19 test) with acute illness after october 15, 2019. patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial. lingering covid-19 symptoms beyond 3 months from onset of acute covid and symptoms have lasted at least 2 months. the onset of covid is considered the earliest of two dates: the date of positive test or the date of first symptoms; lingering symptoms from covid-19 present at the time of randomization. female patients of childbearing potential (as assessed by the overseeing investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. effective methods of contraception must be discussed and approved by the overseeing investigator. must be able to provide informed consent and both willing and able to comply with study requirements. |
|
Exclusion criteria
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
patients who had mechanical ventilation or extracorporeal membrane oxygen (ecmo) for covid-19; current end-organ failure, organ transplantation, or current hospitalization in acute care hospital; contraindications to all of the study interventions; co-enrolment in another interventional trial (co-enrolment in an observational study is permitted); currently pregnant or breastfeeding. |
|
Number of arms
Last imported at : Sept. 1, 2022, 10 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
University Health Network, Toronto |
|
Inclusion age min
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Canada |
|
Type of patients
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
|
Severity scale
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
1000 |
|
primary outcome
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
SF-36 physical component score (PCS) |
|
Notes
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Aug. 25, 2022, 9 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Sept. 1, 2022, 10 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 618, "treatment_name": "Ibudilast", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 971, "treatment_name": "Pentoxifylline", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |