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Trial · NCT05085574

Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)

NCT05085574, Phase 2, Withdrawn, Leidos Life Sciences

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1). Trials, record NCT05085574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05085574

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)
NCT number
NCT05085574
Status
Withdrawn
Phases
Phase 2
Enrollment
0 participants, actual
Lead sponsor
Leidos Life Sciences
Conditions
2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, 2019-nCoV Infection, COVID-19 Pandemic, COVID-19 Virus Disease, COVID-19 Virus Infection, Covid19, Coronavirus Disease 2019, SARS-CoV-2 Infection, SARS-CoV-2 Acute Respiratory Disease, COVID-19
Interventions
Famotidine, Celecoxib, Placebo
First posted
2021-10-20
Last updated
2023-10-10

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime-to-event to achieve WHO level ≤330 daysEvaluation of the time-to-event to achieve a WHO level score ≤3
PrimaryDeath rate30 daysEvaluation of the time-to-event where all-cause mortality occurs
SecondaryHospital discharge to chronic palliative care30 daysMeasured incidence of hospital discharge to chronic palliative care
SecondaryHospital discharge with no additional medical care30 daysMeasured incidence of hospital discharge with no additional medical care required
SecondaryRelated adverse events (AEs) and serious adverse events (SAEs)90 daysMeasured incidence of related AEs and SAEs
SecondaryStudy discontinuation due to related AEs or SAEs90 daysMeasured incidence of study discontinuation due to related AEs or SAEs
OtherPharmacokinetic (PK) endpoint-Assess area under the curve14 daysMeasure area under the curve (AUC) for famotidine and celecoxib combination in 10 patients per group
OtherPharmacokinetic (PK) endpoint-Assess time to maximum plasma concentration14 daysMeasure time to maximum plasma concentration (tmax) for famotidine and celecoxib combination in 10 patients per group
OtherPharmacokinetic (PK) endpoint-Assess maximum serum concentration14 daysMeasure maximum serum concentration (Cmax) for famotidine and celecoxib combination in 10 patients per group
OtherExploratory endpoint-Incidence of symptom reduction14 daysCumulative incidence of clinically significant symptom reduction (severity and duration) using COVID-19 Symptom Score

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05085574

GET https://conductscience.org/api/trials/v1/NCT05085574/registered