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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05085574 |
|
Full text link
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
brian.a.roberts@leidos.com |
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Registration date
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
2021-10-20 |
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Recruitment status
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Dec. 11, 2021, 1 a.m. Source : ClinicalTrials.gov |
inclusion criteria: male or female participants must be at least 18 years of age, inclusive, at the time of signing the informed consent form. confirmed covid-19 or symptom onset within 7 days of hospitalization, as shown by medical history, physical exam, and laboratory tests (pcr), and who have been hospitalized for covid-19 at who grade 4-5. contraceptive use by men or women should be consistent with appendix 4 of the master protocol (ldos-21-001). capable of understanding and providing a signed informed consent form. reliable access to the internet. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
participants are excluded from the study if any of the following criteria apply: pregnant or breastfeeding history of hiv ongoing treatment that cannot be temporarily discontinued during the study: anti-inflammatory treatment (nonsteroidal anti-inflammatory drugs [nsaids]);corticosteroids; antimalarials; antiarrhythmics; tricyclic antidepressants; natalizumab; quinolones; macrolides; and agalsidase alfa and beta drugs dependent on gastric ph for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir; tizanidine (cyp1a2) substrate; drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [ssris]/serotonin norepinephrine reuptake inhibitors [snris]); angiotensin converting enzyme (ace) inhibitors, angiotensin receptor blockers (arb), or beta-blockers; diuretics; digoxin ongoing famotidine, celecoxib, or other covid-19 clinical investigational treatment(s) within the past 30 days or current participation in another investigational clinical trial history of immunosuppression history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids rejection of participation at the discretion of the principal investigator or sponsor any contraindication for famotidine or celecoxib treatment: a. famotidine or celecoxib hypersensitivity; b. retinopathy, visual field or visual acuity disturbances; c. history of cardiovascular disease, such as congestive heart failure, qt prolongation, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias, as determined at screening electrocardiogram (ecg) or medical history; d. potassium <3 meq/l (milliequivalent/liter) as determined at visit 1; e. aspartate aminotransferase (ast) or alanine aminotransferase (alt) >5 upper normal limit, as determined at visit 1; f. previous myocardial infarction; e. myasthenia gravis; h. psoriasis or porphyria; i. glomerular clearance, 60 ml/min; j. previous history of severe hypoglycemia; k. known or suspected to be poor cyp2c9 metabolizers based on genotype or previous history or experience with other cyp2c9 substrates, such as warfarin and phenytoin; l. moderate or severe hepatic impairment, e.g., child-pugh class b or c. |
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Number of arms
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Leidos Life Sciences |
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Inclusion age min
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
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Severity scale
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
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Total sample size
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
404 |
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primary outcome
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Death rate;Time-to-event to achieve WHO level ≤3 |
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Notes
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Oct. 22, 2021, 10 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1991, "treatment_name": "Celecoxib+famotidine", "treatment_type": "Non-steroidal anti-inflammatory+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |