Protocol summary

Study aim
Evaluation the effect of lithium carbonate in covid-19 patients
Design
A randomized, blinded, placebo controlled clinical trial with a parallel group design of 40 patients, randomizing with the table of random numbers.
Settings and conduct
This study will be performed on outpatients. In this study, 40 patients with covid-19 disease were selected and randomly assigned to two groups of 20 individuals. Patients in the standard diet control group will receive standard coronavirus treatment with placebo. In addition to the standard diet, patients in the treatment group will be treated with 300-900 mg/day of lithium carbonate for at least 2 weeks. Patients are monitored at intervals of 3 days, 1 week and 2 weeks after receiving the drug or placebo in terms of time interval until clinical and laboratory symptoms improve.
Participants/Inclusion and exclusion criteria
People aged 18-65 years old with a diagnosis of coronavirus based on clinical and laboratory symptoms;home quarantine and outpatients
Intervention groups
The control group receives standard anti-coronavirus drugs with placebo. In addition to the common anticorona drugs, the treatment group also receives lithium carbonate.
Main outcome variables
Time interval until lymphopenia improves, Time interval until CRP normalizes, Time interval until clinical symptoms improve (fever, cough and myalgia)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20081019001369N5
Registration date: 2020-04-26, 1399/02/07
Registration timing: prospective

Last update: 2020-04-26, 1399/02/07
Update count: 0
Registration date
2020-04-26, 1399/02/07
Registrant information
Name
Hossein Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1193
Email address
hosseinzadehh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-02, 1399/02/13
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of lithium in improving the clinical and laboratory symptoms of patients with COVID-19
Public title
Effect of lithium carbonate on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with covid-19 symptoms Indication of home quarantine outpatients aged range 18-65 uears old
Exclusion criteria:
Patients connected to acatheter or under chemotherapy Patients taking cytotoxic drugs or corticosteroids Patients having a psychological problem now or in the past or with a history of psychological problem in first class family Patients who used cigarette at least one month before the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in three stages: 1- Random sequence generation: this step simple or limited randomization will be done based on a table of random numbers 2- Allocation concealment: which is done in the form of coded boxes (numbered drug containers) with a random sequence. In this method, a number of boxes with the same shape and size are numbered based on random sequences and contain drugs or placebo that have a completely similar appearance. 3- Execution of random allocation process: A: Identify the person who creates the random sequence B: A person who evaluates and registers researchers in terms of inclusion and exclusion criteria C: The person who assigned the participants to the groups: infectious diseases specialist The main researcher of the project, who creates a random sequence, does not interfere in other stages of randomization, including registration and allocation of participants, and the person involved in creating a random program is separate from other researchers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are given as a same-color and –size tablets in boxes labeled with the letters A and B in box. The medical staff, the patient and the data collector are not aware of the nature of the drug or placebo, and only the executor of research project is aware of the nature of the contents of the two kind of tablets.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Mashhad University of Medical Sciences
Street address
Blv.Vakilabad 2- School of Pharmacy-1365-91775
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Approval date
2020-04-23, 1399/02/04
Ethics committee reference number
IR.MUMS.REC.1399.145

Health conditions studied

1

Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 Disease

Primary outcomes

1

Description
Time interval until clinical symptoms improve
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
time of recovery

Secondary outcomes

1

Description
Fever
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
Thermometer

2

Description
lymphopenia
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
Cell counter device

3

Description
CRP
Timepoint
3 days, 1 week and 2 weeks after treatment
Method of measurement
CRP kit

Intervention groups

1

Description
Intervention group: In addition to the standard treatment regimen for COVID-19, the lithium carbonate tablets (300 mg/day to 900 mg/day) will be given for 2 weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients on the standard treatment regimen for COVID-19 will receive placebo tablets once a day for 2 weeks. The placebo is formulated in tablets of the same shape and size as the drug tablets and contains inert agents.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminejad Hospital
Full name of responsible person
Javad Dehghan Nayyeri
Street address
Mofateh boulevard, Vahid street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3273 7011
Email
DehghanMJ@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Hosseinzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Blv. Vakilabad2-School of Pharmacy, 1365-91775
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1193
Fax
+98 51 1882 3251
Email
hosseinzadehh@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Hosseinzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Blv. Vakilabad2-School of Pharmacy, 1365-91775
City
mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1193
Fax
+98 51 1882 3251
Email
hosseinzadehh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Hosseinzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Blv. Vakilabad2-School of Pharmacy, 1365-91775
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954+98
Phone
+98 51 3180 1193
Fax
+98 51 1882 3251
Email
hosseinzadehh@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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