Mefenamic acid as a treatment for COVID-19

Phase 2

• Conditions: COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Nidovirales Infections; Betacoronavirus

• Registration Number: RPCEC00000388
• Lead Sponsor: Medical School of the University of Colima, Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Study Completion: 2021-10-01
• Results First Posted: 2021-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Outpatients treated at home (without pneumonia and with peripheral blood oxygen saturation equal to or greater than 90% breathing ambient air):
1. Patients diagnosed with COVID-19, with uncomplicated disease.
2. Age: 18 years - 85 years old.
3. Acceptance in writing, with prior information.

Exclusion Criteria

1. Rheumatoid arthritis.
2. Autoimmune diseases.
3. Previously diagnosed cardiac diseases (ischemic).
4. Chronic decompensated systemic disease prior to the diagnosis of COVID-19.
5. Creatinine 1.25 times higher than the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method), prior to the diagnosis of COVID-19.
6. Blood hemoglobin less than 10g / Dl, prior to the diagnosis of COVID-19.
7. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or appearance of hematuria or proteinuria greater than 300 milligrams / day.
8. Intestinal pseudo-obstruction. Defined as abdominal pain, with airborne levels on radiographs of the AP abdomen and lateral foot.
9. Pregnant and lactating women.
10. Drug addiction (illicit drugs).
11. Known liver disease prior to the diagnosis of COVID-19 with a doubling of liver function tests (Aspartatoamine transferase (AST), Alaninoamine transferase (ALT), Alkaline phosphatase, Bilirubins).
12. Presence of Cancer.
13. Other pathologies at the discretion of the researcher.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptable symptom status of the patient. (Days to reach a state of acceptable symptoms, determined as the number of days that elapsed from the start of treatment until the patient answered with a Yes to the following question: Considering all the different ways your disease is affecting you, if you were to stay in this state for the next few months, do you consider that your current state is satisfactory? ”: Yes or No.) Measurement time: Daily, from patient randomization (baseline) to day 20.

Secondary Outcome Measures

Name	Time	Method
1. Adverse Events-AE (Present or Absent. AE will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5). Measurement time: Daily until 20th day or until patient outcome (cure or death). <br>2. Change in laboratory test values (Dimero D, C-reactive protein, fibrinogen and erythrocyte sedimentation rate). Measurement time: Basal, at 2, 4, 6 and 14 days.