Protocol summary
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Study aim
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Evaluation the effect of minocycline in covid-19 patients
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Design
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A randomized, blinded, placebo controlled clinical trial
with a parallel group design of 40 patients, randomizing
with the table of random numbers.
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Settings and conduct
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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 100 mg of minocycline BID
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.
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Participants/Inclusion and exclusion criteria
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People over 18 years of age with a diagnosis of
coronavirus based on clinical and laboratory
symptoms;home quarantine and outpatients
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Intervention groups
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The control group receives standard anti-coronavirus
drugs with placebo. In addition to the common anticorona
virus drugs, the treatment group also receives
minocycline.
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Main outcome variables
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Time interval until lymphopenia improves Time interval
until CRP normalizes Time interval until clinical
symptoms improve (fever, cough and myalgia)
General information
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Reason for update
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Correction of minocycline spell
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20081019001369N4
Registration date:
2020-04-11, 1399/01/23
Registration timing:
prospective
Last update:
2020-04-13, 1399/01/25
Update count:
1
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Registration date
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2020-04-11, 1399/01/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-20, 1399/02/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of minocycline against COVID-19
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Public title
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Effect of minocycline on COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with covid-19 symptoms Indication of home quarantine and outpatient medication;
Age range 18 to 65
Exclusion criteria:
Patients connected to a catheter
Patients under chemotherapy
Patients taking cytotoxic drugs or corticosteroids
Pregnant and lactating patients
Patients with severe renal insufficiency
Patients with liver failure
Diabetic patients
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The drug and placebo are given as a same-color and
–size capsules 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 capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-06, 1399/01/18
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Ethics committee reference number
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IR.MUMS.REC.1399.053
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19 Disease
Primary outcomes
1
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Description
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Time interval until clinical symptoms improve
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Timepoint
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3 days, 1 week and 2 weeks after treatment
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Method of measurement
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time of recovery
Secondary outcomes
1
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Description
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Fever
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Timepoint
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3 days, 1 week and 2 weeks after treatment
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Method of measurement
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Thermometer
2
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Description
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Lymphopenia
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Timepoint
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3 days, 1 week and 2 weeks after treatment
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Method of measurement
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Cell counter device
3
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Description
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CRP
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Timepoint
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3 days, 1 week and 2 weeks after treatment
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Method of measurement
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CRP kit
Intervention groups
1
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Description
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Intervention group: In addition to the standard treatment regimen forCOVID-19, the minocycline capsule 100 mg will be given two times a day for 2 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients on the standard treatment regimen for COVID-19 will receive placebo capsules two times a day for 2 weeks. The placebo is formulated in capsules of the same shape and size as the drug capsules and contains avicel and aerosil.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable