Protocol summary
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Study aim
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Evaluation of the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 (Before intubation phase) who have not responded to the standard three-drug protocol (hydroxychloroquine / chloroquine + lupinavir / ritonavir + ribavirin).
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Design
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Clinical trial with no control group, not blinded and not randomized
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Settings and conduct
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This study will be conducted on 50 patients admitted to Imam Reza hospital in Mashhad who diagnosed with COVID-19 and have not responded to the standard three-drug protocol. Convenience sampling will be used. These patients will receive intravenous immunoglobulin (IVIg) before entering the intubation phase. Also patients under prophylaxis from thrombosis, in the case of the absence of contraindication, will receive heparin with prophylaxis dose. Patient's symptoms and their severity, clinical examinations and findings of chest CT scan will be evaluated before and after treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age range within 18 to 25 years old; definitive diagnosis with COVID-19; having one of the factors of decrease in consciousness level, RR≥24، BP<90/60, Multi-lobe lung problem and hypoxemia; not responding to standard three-drug protocol of hydroxychloroquine/chloroquine + lupinavir/ritonavir + ribavirin. Non-inclusion criteria: comorbidities such as heart diseases.
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Intervention groups
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Patients with severe clinical symptoms for whom the standard three-drug protocol (hydroxychloroquine / chloroquine + lupinavir / ritonavir + ribavirin) was not responsive, receive intravenous immunoglobulin (IVIg) before entering the intubation phase. They will receive 0.4-0.5 gr/kg/day of IVIg in 3-5 doses (equal to about 30g daily in a case with 60 kg body weight).
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Main outcome variables
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Fever; respiration rate; pulse rate; SpO2; WBC; number of lymphocytes; LDH; Signal Recognition Particle (SRP); findings of CT scan
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200325046859N1
Registration date:
2020-04-02, 1399/01/14
Registration timing:
prospective
Last update:
2020-04-23, 1399/02/04
Update count:
1
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Registration date
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2020-04-02, 1399/01/14
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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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2020-04-04, 1399/01/16
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Expected recruitment end date
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2020-05-05, 1399/02/16
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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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Evaluation of the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 (Before intubation phase) who have not responded to treatment with the standard three-drug protocol (hydroxychloroquine / chloroquine + lupinavir / ritonavir + ribavirin)
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Public title
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The efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 who have not responded to standard three-drug protocol
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Informed consent for inclusion in the study
Age range within 18 to 25 years old
Definitive diagnosis with COVID-19
Having one of the factors of decrease in consciousness level, RR≥24، BP<90/60, Multi-lobe lung problem and hypoxemia
Certainty about non responsiveness of standard three-drug protocol of hydroxychloroquine / chloroquine + lupinavir / ritonavir + ribavirin
Exclusion criteria:
Sensitivity to IVIg
Having a comorbidities such as heart diseases that IVIg cannot be used
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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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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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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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2020-03-30, 1399/01/11
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Ethics committee reference number
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IR.MUMS.REC.1399.013
Health conditions studied
1
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Description of health condition studied
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COVID-19 disease
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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, virus identified
Primary outcomes
1
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Description
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fever
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Timepoint
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before and after treatment
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Method of measurement
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Thermometer
2
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Description
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respiration rate
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Timepoint
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before and after treatment
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Method of measurement
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counting the number of breaths patients take per minute
3
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Description
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findings of chest CT scan
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Timepoint
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before and after treatment
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Method of measurement
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CT scan machine
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Description
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pulse
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Timepoint
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before, during and after treatment
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Method of measurement
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patient monitoring device
5
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Description
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SpO2
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Timepoint
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before, during and after treatment
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Method of measurement
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patient monitoring device
6
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Description
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WBC
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Timepoint
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before and after treatment
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Method of measurement
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biochemical tests
7
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Description
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number of lymphocytes
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Timepoint
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before and after treatment
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Method of measurement
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biochemical tests
8
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Description
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Lactate dehydrogenase
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Timepoint
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before and after treatment
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Method of measurement
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biochemical tests
9
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Description
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C-Reactive Protein (CRP)
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Timepoint
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before and after treatment
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Method of measurement
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biochemical tests
Intervention groups
1
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Description
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Intervention group: Patients with severe clinical symptoms for whom the standard three-drug protocol (hydroxychloroquine / chloroquine + lupinavir / ritonavir + ribavirin) was not responsive receive intravenous immunoglobulin (IVIg) before entering the intubation phase. They will receive 0.4-0.5/g/kg/day of IVIg in 3-5 doses with each dose being equal to about 30g with a weight of 60 kg. Also patients under prophylaxis from thrombosis, in the case of the absence of contraindication, will receive heparin with prophylaxis dose.
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data can be shared after patients are made unidentifiable.
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When the data will become available and for how long
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Data can be accessible 6 months after results are published.
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To whom data/document is available
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Data will be available for researchers in universities and other scientific institutes.
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Under which criteria data/document could be used
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Carrying out analysis on data is permitted.
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From where data/document is obtainable
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Data can be accessible through sending an email to the corresponding author.
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What processes are involved for a request to access data/document
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After sending a request email to the corresponding author, data will be sent in 1 month.
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Comments
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