The efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 who have not responded to standard three-drug protocol

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200325046859N1

Enrollment

Registered

2020-04-02

Start date

2020-04-04

Completion date

Unknown

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 disease. COVID-19, virus identified

Interventions

Intervention group: Patients with severe clinical symptoms for whom the standard three-drug protocol (hydroxychloroquine / chloroquine + lupinavir / ritonavir + ribavirin) was not responsive receive i

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria: Sensitivity to IVIg Having a comorbidities such as heart diseases that IVIg cannot be used

Design outcomes

Primary

Measure	Time frame
Fever. Timepoint: before and after treatment. Method of measurement: Thermometer.;Respiration rate. Timepoint: before and after treatment. Method of measurement: counting the number of breaths patients take per minute.;Findings of chest CT scan. Timepoint: before and after treatment. Method of measurement: CT scan machine.;Pulse. Timepoint: before, during and after treatment. Method of measurement: patient monitoring device.;SpO2. Timepoint: before, during and after treatment. Method of measurement: patient monitoring device.;WBC. Timepoint: before and after treatment. Method of measurement: biochemical tests.;Number of lymphocytes. Timepoint: before and after treatment. Method of measurement: biochemical tests.;Lactate dehydrogenase. Timepoint: before and after treatment. Method of measurement: biochemical tests.;C-Reactive Protein (CRP). Timepoint: before and after treatment. Method of measurement: biochemical tests.	—

Measure

Time frame

Fever. Timepoint: before and after treatment. Method of measurement: Thermometer.;Respiration rate. Timepoint: before and after treatment. Method of measurement: counting the number of breaths patients take per minute.;Findings of chest CT scan. Timepoint: before and after treatment. Method of measurement: CT scan machine.;Pulse. Timepoint: before, during and after treatment. Method of measurement: patient monitoring device.;SpO2. Timepoint: before, during and after treatment. Method of measurement: patient monitoring device.;WBC. Timepoint: before and after treatment. Method of measurement: biochemical tests.;Number of lymphocytes. Timepoint: before and after treatment. Method of measurement: biochemical tests.;Lactate dehydrogenase. Timepoint: before and after treatment. Method of measurement: biochemical tests.;C-Reactive Protein (CRP). Timepoint: before and after treatment. Method of measurement: biochemical tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRozita Khodashahi

Mashhad University of Medical Sciences

khodashahir@mums.ac.ir+98 51 385022406

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026