Therapy for COVID-19-Phase I-II

Phase 1

• Conditions: COVID-19; SARS-CoV-2; covid-19; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000309
• Lead Sponsor: Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Results First Posted: 2020-09-10
• Study Completion: 2021-07-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A) For 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 - 75 years old.
3. Acceptance in writing, with prior information.

B) For hospitalized patients (with pneumonia or peripheral blood oxygen saturation less than 90% breathing ambient air or requiring mechanical ventilation):
1. Patients diagnosed with COVID-19, with mild or severe pneumonia hospitalized.
2. Age: 18 years - 75 years old.
3. Acceptance in writing, with prior information.

Exclusion Criteria

FOR ALL PATIENTS
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
Disease progression (present or absent). Measurement time: Daily until 20th day or until patient outcome (cure or progression).<br>Patients treated at home. The progression will be present when hospitalization or death occurs.<br>In hospitalized patients: The progression will be present when they are in the usual hospital floor and without a ventilator, progression is considered when there is death or admission to the Intensive Care Unit (ICU) or requiring mechanical ventilation.<br>Patients enrolled in the trial after admission to the ICU or already on mechanical ventilation. The progression will be present when death occurred.

Secondary Outcome Measures

Name	Time	Method
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>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.