Revisions for Mefenamic acid as a treatment for COVID-19 | Registro Público Cubano de Ensayos Clínicos

Revision of 31 August 2021 - 2:47pm:

Mefenamic acid as a treatment for COVID-19

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

MEFECOVID-19

Scientific title:

Efficacy and safety of mefenamic acid for the treatment of inflammatory symptoms in patients with COVID-19. (COVID-19)

Acronym of Scientific Title:

MEFECOVID-19

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

1) General Hospital of Zone 1, Mexican Institute of Social Security (IMSS-Colima), Mexico. 2) Medical School of the University of Colima, Mexico

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jose

Last name:

Guzman-Esquivel

Medical Specialty :

Medical Researcher with a specialty in urology

Affiliation:

General Hospital of Zone 1, Mexican Institute of Social Security (IMSS-Colima), Mexico.

Postal address:

Lapislazuli Avenue 250, Colonia El Haya.

City:

Villa de Alvarez, Colima

Country:

Mexico

Zip Code:

28984

Telephone:

+52-3123163460

Email address:

pepeguzman_esquivel@outlook.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

01/08/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

COVID-19

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Mefenamic acid (Experimental group): Mefenamic acid in tablets, 500mg (orally) every 8 hours for 7 days. Moreover, the patient will receive usual treatment consisting of Paracetamol 500 mg (orally) every 6 hours and omeprazole 20 mg a day for 10 days. Other medications may be added at the discretion of the treating physician as deemed necessary by the patient. Placebo (Control group): Placebo tablets (orally), one every 8 hours for 7 days. Moreover, the patient will receive usual treatment consisting of Paracetamol 500 mg (orally) every 6 hours and omeprazole 20 mg a day for 10 days. Other medications may be added at the discretion of the treating physician as deemed necessary by the patient.

Intervention code:

Mefenamic Acid

Acetaminophen

Omeprazole

Placebos

Tablets

Administration, Oral

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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). 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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

85 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Jose

Last Name:

Guzman-Esquivel

Specialty:

Medical Researcher with a specialty in urology

Affiliation:

General Hospital of Zone 1, Mexican Institute of Social Security (IMSS-Colima), Mexico.

Postal Address:

28984

City:

Villa de Alvarez, Colima.

Country:

Mexico

Zip Code:

28984

Telephone:

+52-3123163460

Email :

pepeguzman_esquivel@outlook.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ivan

Last Name:

Delgado-Enciso

Specialty:

General Medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

Country:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email :

ivan_delgado_enciso@ucol.mx

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Research Ethics Committee 6018 H Gral Zona -MF- NUM 1 (CONBIOETICA 19 CI 06 010 002)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

29/07/2020

Postal address of Ethic Committee :

Avenida Lapislazuli No. 250, El Haya, 28984 Villa de Alvarez, Colima, Mexico.

Telephone:

+52-5556276900 extensión 21230

Email:

comite.eticainv@imss.gob.mx

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

40

Study completion date:

21/02/2021

Date of available results:

01/10/2021

Date of first publication:

01/12/2021

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000388

Date of Registration in Primary Registry:

31/08/2021

Record Verification Date:

2021/08/31

Next update date:

2022/08/31

Link to the spanish version:

Click here

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Mefenamic acid as a treatment for COVID-19

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31 August 2021 - 2:42pm by Gladys		31 August 2021 - 2:47pm by lazara

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