COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Experimental Group: Lithium Carbonate + Cuban national action protocol for COVID-19 version 1.6
Scheme of Oral Lithium Carbonate (250 mg)
First day: 1 tablet with lunch and 1 tablet with dinner.
Secon
Lithium Carbonate
Tablets
Administration, Oral
Sponsors
Institute of Basic and Preclinical Sciences "Victoria de Giron"
MedSol Laboratories, BioCubaPharma
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient who expresses his consent to participate in the study in writing 2. Patients with positive RT-PCR 3. Age greater than or equal to 19 years 4. Mild or moderate symptomatic patients
Exclusion criteria
Exclusion criteria: 1. Patients with decompensated chronic diseases (high blood pressure, diabetes mellitus, ischemic heart disease, chronic obstructive pulmonary disease, asthma, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, Addison's disease) 2. Patients with immunosuppression due to cancer, HIV or long-term treatment with immunosuppressants 3. Patients with chronic kidney failure 4. Patients with digestive autoimmune diseases (Crohn's disease, ulcerative colitis, among others) or thyroid 5. Pregnant or breastfeeding 6. Patients with treatments that deplete sodium or maintain a sodium restrictive diet 7. Patients with psychiatric illnesses or mental disabilities that prevent them from expressing their willingness to participate in the study or make its evaluation difficult 8. Patients hypersensitive to lithium 9. Lactose intolerant patients 10. Woman of childbearing age who does not use contraception and does not undertake to use it for at least one month after the end of the study treatment. 11. Patient participating in another clinical trial at the time of selection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythrosedimentation (values in mm/h). Measurement time: Every 72 hours for a maximum of 15 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prognosis biomarkers. 1. C-Reactive Protein (Positive or Negative, or values in mg/mL). Measurement time: Every 72 hours for a maximum of 15 days. 2. Neutrophils (values in cel/mL). Measurement time: Every 72 hours for a maximum of 15 days. 3. Lymphocytes (values in cel/ mL). Measurement time: Every 72 hours for a maximum of 15 days. 4. Neutrophil lymphocyte index (according to neutrophil-lymphocyte ratio). Measurement time: Every 72 hours for a maximum of 15 days. 5. D-dimer (values in mcg / mL). Measurement time: Every 72 hours for a maximum of 15 days. 6. Platelets (values in cel/ mL). Measurement time:Every 72 hours for a maximum of 15 days. 7. Blood glucose (values in mmol / L). Measurement time: Every 72 hours for a maximum of 15 days. 8. Temperature (values in celsius grade). Measurement time: Every 72 hours for a maximum of 15 days. 9. Visceromegaly (Present or Absent). Measurement time: Every 72 hours for a maximum of 15 days. Therapeutic variables 10. Severity of the patient's clinical picture (Mild, Moderate, Severe). Measurement time: daily for a maximum of 15 days. 11. Presence of clinical signs / symptoms of COVID-19 (Yes, No). Measurement time: daily for a maximum of 15 days. 12. Hospital service where the patient enters and passes through (Respiratory isolation room, Intensive Surveillance Unit, Intensive Care Unit). Measurement time: at the beginning and at the hospital discharge 13. Negative RT-PCR (Positive or Negative). Measurement time: Days 0, 5, 7, 9, 11 and at hospital discharge 14. Hospital stay (Time, in days, from admission until to discharge). Measurement time: At hospital discharge 15. Status of the patient (death or alive). Measurement time: At hospital discharge 16. Presence of sequelae (Yes, No): Measurement time: At one month of hospital discharge 17. Adverse Events (AE) (Occurrence of some AE in the subject (yes / no); Description of the AE (name of the AE); Duration of the AE (hours, days, weeks); AE intensity (mild, moderate, sev | — |
Countries
Cuba
Contacts
Public ContactOrmany Soriano Torres
Institute of Basic and Preclinical Sciences "Victoria de Giron"
Outcome results
None listed