Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)

COVID-19 Clinical Trial

Official title:

A Virtual Phase 2 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of the Combination of Famotidine and Celecoxib as a Post-exposure Prophylaxis (PEP) for Newly-infected COVID-19 Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05077969
• Other study ID #: LDOS-21-001-02
• Status: Terminated
• Phase: Phase 2
• Start date: December 29, 2021
• Est. completion date: July 8, 2022

Study information

• Verified date: July 2022
• Source: Leidos Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

Description:

Qualifying patients will have been confirmed positive for COVID-19 and have symptoms of World Health Organization (WHO) Ordinal Scale for Clinical Improvement with scores of ≤3 on the 11-point scale and will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 659 participants per group, as follows:

Group 1 (study product) participants will receive 80 mg famotidine by mouth (PO) 4 times per day (QID) + 400 mg celecoxib as a first dose, followed by 200 mg celecoxib (PO) 2 times per day (BID), for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.

Group 2 (reference therapy) participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.

Safety and efficacy of famotidine and celecoxib will be evaluated.

This is a completely virtual trial and you can participate from your own home. Please call 1-888-370-9330 to speak to someone regarding study participation in your area.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 8, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 SARS-CoV-2 polymerase chain reaction (PCR) positive patient within 5 days of enrollment, as shown by medical history and reported PCR test result.

• Reports having one or more symptoms consistent with SARS-CoV-2, as defined in Master Protocol Appendix 3 Table 4.

• COVID-19 diagnosis must be WHO grade =3.

• Contraceptive use by men or women should be consistent with Appendix 4 of the Master protocol (LDOS-21-001).

• Reliable access to the Internet via a browser installed on personal device or computer.

• Capable of understanding and providing signed informed consent.

Exclusion Criteria:

• Pregnancy or breastfeeding

• Ongoing antiviral or antiretroviral treatment

• Known history of HIV

• Ongoing anti-inflammatory treatment that cannot be temporarily discontinued during the study. This includes nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids - including Dexamethasone (dexamethasone administration restricted to recommended standard of care use per NIH COVID-19 Guidelines)

1. drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;

2. tizanidine (CYP1A2) substrate;

3. drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors (SNRIs]);

4. angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), or beta-blockers;

5. diuretics;

6. digoxin

• Ongoing treatment that cannot be temporarily discontinued during the study, with:

antimalarials, antiarrhythmics, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta

• Ongoing famotidine or celecoxib or other COVID-19 clinical investigational treatment(s) within the past 30 days, or current participation in another investigational clinical trial

• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• History of immunosuppression

• Rejection of participation by Principal Investigator or Sponsor

• Any contraindication for famotidine or celecoxib treatment:

1. Famotidine or celecoxib hypersensitivity

2. Retinopathy, visual field or visual acuity disturbances

3. History of cardiovascular disease, such as congestive heart failure, QT prolongation, myocardial infarction, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias

4. Myasthenia gravis

5. Psoriasis or porphyria

6. History of renal failure/dialysis or a glomerular clearance <60 mL/min

7. History of severe hypoglycemia

8. Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C

9. 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

Related Conditions & MeSH terms

• 2019 Novel Coronavirus Infection
• Communicable Diseases
• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19
• COVID-19 Pandemic
• COVID-19 Virus Disease
• COVID-19 Virus Infection
• Covid19
• Infections
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease
• SARS-CoV2 Infection
• Virus Diseases

Intervention

Drug:
• Famotidine
80 mg tablet, QID for 14 days
• Celecoxib
400 mg (initial dose), then 200 mg capsule, BID for 5 days
• Placebo
tablet, QID for 14 days; capsule, BID for 5 days

Locations

Country	Name	City	State
United States	Integrated Health Solutions USA, Inc.	Atlanta	Georgia
United States	Integrated Therapeutic Solutions USA, Inc.	Charleston	South Carolina
United States	Integrated Therapeutic Solutions USA, Inc.	Chicago	Illinois
United States	Integrated Therapeutic Solutions USA, Inc.	Dallas	Texas
United States	Integrated Therapeutic Solutions USA, Inc	Dearborn	Michigan
United States	Integrated Therapeutic Solutions USA, Inc	Frederick	Maryland
United States	Integrated Therapeutic Solutions USA, Inc	Gaithersburg	Maryland
United States	Integrated Therapeutic Solutions USA, Inc	Hazlehurst	Georgia
United States	Integrated Therapeutic Solutions USA, Inc.	Huntingdon	Pennsylvania
United States	Integrated Therapeutic Solutions USA, Inc.	Miami	Florida
United States	Integrated Therapeutic Solutions USA, Inc.	New York	New York
United States	Integrated Therapeutic Solutions USA, Inc.	Newark	New Jersey
United States	Integrated Therapeutic Solutions USA, Inc.	Newport Beach	California
United States	Integrated Therapeutic Solutions USA, Inc	Prospect	Kentucky
United States	Integrated Therapeutic Solutions USA, Inc	Rockville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Leidos Life Sciences	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity	Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.	Through Day 30
Primary	Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality).	Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.	Through Day 30
Secondary	Incidence of Treatment-Emergent Serious Adverse Events (SAE) as assessed by participant withdrawal	Study discontinuation will be measured in whole units, by number of participants who are removed with the reason of "SAE" and captured by the electronic data capture system.	90 days
Secondary	Incidence of death	Deaths will be captured by whole numbers, by number of participants who are removed from the study with reason as "death" in the electronic data capture system.	90 days

External Links

•   Website to learn more about this virtual COVID-19 study