Lithium Carbonate-COVID-19- mild and moderate -Exploratory / Phase II

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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:

CLOC-2

Scientific title:

Exploratory, controlled, randomized and open clinical trial to evaluate the therapeutic effect and safety of oral Lithium Carbonate, combined with standard therapy, in patients with mild or moderate COVID-19. (COVID-19)

Acronym of Scientific Title:

CLOC-2

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

MedSol Laboratories Institute of Basic and Preclinical Sciences "Victoria de Giron" Ministry of Public Health of Cuba (MINSAP)

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Hermes

Last name:

Fundora Hernandez

Medical Specialty :

First Degree Specialist in Immunology and Integral General Medicine

Affiliation:

Julio Trigo Lopez Hospital

Postal address:

Calzada of Bejucal km 7½, Parraga, Arroyo Naranjo

City:

Havana

País:

Cuba

Zip Code:

10900

Telephone:

+53-54223598

+53-76433128

Email address:

hermesfundorah@gmail.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:

Cuba

Clinical sites:

Not Applicable

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

10/08/2021

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

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

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. Second day: 2 tablets with lunch and 1 tablet with dinner. Third day: 2 tablet with lunch and 2 tablets with dinner. Maximum of 4 tablets daily and for a period no more than 15 days. The intervention also includes at least 2 liters of daily fluids. Control Group: Cuban national action protocol for COVID-19 version 1.6

Intervention code:

Lithium Carbonate

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):

Erythrosedimentation (values in mm/h). Measurement time: Every 72 hours for a maximum of 15 days.

Key secondary outcomes:

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, severe); Causation relationship (certain, probable, Possible, Unlikely, Unrelated, Not assessable); AE intensity (Serious / serious, Not serious / not serious); Attitude regarding the study treatment (no changes, dose modification, temporary or definitive interruption of the study treatment); Treatment need (required and which, did not require); Result of AE (recovered, improved, persists, sequelae, leads to death)). Measurement time: Daily for a maximum of 15 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:

19 years

Maximum age:

None

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:

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

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

192

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:

Ormany

Last Name:

Soriano Torres

Specialty:

First Degree Specialist in Integral General Medicine. Immunology Resident.

Affiliation:

Institute of Basic and Preclinical Sciences "Victoria de Giron"

Postal Address:

146 street, No. 2504 between ave. 25 and 31 ave.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72729338 / +53-58408939

Email :

ormany87@gmail.com

msorianot@infomed.sld.cu

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:

Oliver

Middle Name:

German

Last Name:

Perez Martin

Specialty:

First Degree Specialist in Immunology

Affiliation:

Institute of Basic and Preclinical Sciences “Victoria de Giron”

Postal Address:

146 street, 2504 between 25 and 31, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72032905 / +53-53849242

Email :

oliverperezmartin@gmail.com

Research Ethics Committees

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

Name of Research Ethics Committees:

Julio Trigo Lopez Hospital

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

15/07/2021

Postal address of Ethic Committee :

Calzada de Bejucal km 7½, Arroyo Naranjo, ZC 10900, Havana, Cuba

Telephone:

+53-53907632

Correo electrónico:

joanmarrero@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

25/11/2021

Date of available results:

25/12/2021

Date of first publication:

25/02/2022

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:

RPCEC00000386

Date of Registration in Primary Registry:

05/08/2021

Record Verification Date:

2021/08/05

Next update date:

2022/08/05

Link to the spanish version:

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Lithium Carbonate-COVID-19- mild and moderate -Exploratory / Phase II

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