Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of ketotifen and indomethacin taken together to improve symptoms related with COVID-19. Ketotifen and indomethacin are medications approved by the Food and Drug Administration (FDA) to treat diseases other than COVID-19. Their use in this study is investigational, meaning they have not been approved by the FDA to treat COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sen-Jam Pharmaceutical
• Collaborator: National University, Singapore
• Treatments: Indomethacin; Ketotifen

Criteria

Inclusion Criteria:

1. Adult patients aged 18-75 years

2. Has SARS-CoV-2-positive antigen or molecular diagnostic test (validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay from a sample collected no more than 7 days prior to enrollment.

3. At least two signs or symptoms of disease consistent with acute COVID-19 infection. One of these two symptoms must include cough OR shortness of breath with onset within 7 days prior to randomization. Other symptoms that qualify include:

1. Fever

2. nausea

3. vomiting

4. diarrhea

5. muscle aches

6. fatigue

7. headache

8. loss of smell or taste

9. others that are consistent with acute COVID-19 infection in the opinion of the Investigator.

4. Able and willing to give written or oral informed consent

5. Willing to be an outpatient from Study Day 1 to 14, to provide blood during patient visits on Study Days 1, 3, 5, and 10, return on Study Days 1, 3, 5, 7, 10, 14, and 21 for assessment.

6. Willing to keep a diary of pain medication usage, side effects, and COVID-19 associated symptoms and answer a follow-up questionnaire on Study Day 84.

Exclusion Criteria:

1. Clinical signs and symptoms for severe COVID-19, such as:

1. Need for hospitalization at the time of screening

2. Need for supplemental O2 at the time of screening

2. A person with any of the following laboratory values:

1. AST or ALT >/= 1000 U/L

2. Known serum creatinine > 1.6 mg/dL

3. Prior use of any of the following treatments: COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, IVIG (for COVID-19), or COVID-19 treatments (authorized, approved, or investigational)

4. Current usage (within the last 7 days prior to randomization) of any of the following drugs:

1. anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel.

2. systemic corticosteroids or non-steroidal anti-inflammatory medications for any indication

3. drugs that are known to block the functions of ketotifen, such as propranolol.

4. oral anti-diabetic agents

5. diflunisal or other drugs (or drugs at certain doses) that are contraindicated for concurrent use with Indomethacin

5. Prior vaccination of at least one dose of vaccine for SARS-CoV-2

6. Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational drug SARS-CoV-2

7. Any other clinically significant acute illness within 7 days prior to first study drug administration that would impact outcome assessment.

8. Patients with a history of any gastrointestinal bleeding requiring medical care.

9. Exposure to any new investigational agent within 30 days prior to the study drug administration.

10. Clinically significant abnormal physical examination unrelated to COVID-19 infection that would impact outcome assessment.

11. Females who are pregnant or breast feeding.

12. Current significant medical condition or illness including cardiac arrhythmias, cardiomyopathy or other cardiac disease, advanced renal disease, immunocompromised state including known HIV infection, or any other illness that the Investigator considers should exclude the patient, especially those that require continuation of other medications likely to have an interaction with the study drug. Patients with a history of allergy will not be excluded unless the allergy may be directed to the Study Drug, other NSAIDs, or other tablet ingredient.

13. Any condition that would render the informed consent invalid, or limit the ability of the patient to comply with the study requirements.

14. Inability to comply with completing the outcome assessment measure(s).

15. Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the patient.