Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial
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ClinicalTrials.gov Identifier: NCT04548557 |
Recruitment Status : Unknown
Verified September 2020 by Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore.
Recruitment status was: Not yet recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Biological: intravenous immunoglobulin therapy | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | one group in conventional with routine therapy and interventional group will receive intravenous immunoglobulin therapy |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial |
Estimated Study Start Date : | September 15, 2020 |
Estimated Primary Completion Date : | October 15, 2020 |
Estimated Study Completion Date : | November 15, 2020 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
They will not receive any intervention
|
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Experimental: IVIG group
They will reveive intravenous immunoglobulin therapy
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Biological: intravenous immunoglobulin therapy
It is passive immunization therapy. Plasma therapy is subjected to moderate to severe patients specially, while all effected individuals can take benefit of immunoglobulin therapy because dose of immunoglobulins can be controlled |
- In hospital days [ Time Frame: 14 days or discharge ]total number of days the patient remain in hospital
- 14 day mortality [ Time Frame: 14 days ]mortality if any in the study duration of 14 days
- D-dimers [ Time Frame: 7 days ]reduction in D-dimers (< 250 ng/mL)
- C-reactive protein [ Time Frame: 7 days ]reduction in C-Reactive protein (less than 10 mg/L)
- Oxygen saturation [ Time Frame: 7 days ]improvement in oxygen saturation (pulse oximeter readings within range of 95 to 100%)
- TNF alpha [ Time Frame: 7 days ]reduction in TNF alpha after IVIG treatment (upto 8.1 pg/mL)
- IL-6 [ Time Frame: 7 days ]reduction in IL-6 after IVIG treatment
- Ferritin [ Time Frame: 7 days ]reduction in ferritin levels after IVIG treatment
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 days ]safety and tolerability

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age > 18 yrs
- Both genders
- Lab Confirmed COVID-19 infection by PCR or plasma positive of specific antibody against COVID-19
- In hospital treatment ≥ 72 hours
- Admitted patients
- Mild to moderately severe patients
Exclusion Criteria:
- Exist of other evidences that can explain pneumonia including but not limited to influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.
- Patients with respiratory diseases other than Covid-19 infection
- Pregnant and breastfeeding women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548557
Contact: riffat mehboob, Ph.D | +923313380909 | mehboob.riffat@gmail.com | |
Contact: Fridoon J Ahmad, Ph.D |
Pakistan | |
University of Health Sciences | |
Lahore, Punjab, Pakistan, 54000 | |
Contact: Riffat o Mehboob, PhD mehboob.riffat@gmail.com | |
Contact: Fridoon Jawad Ahmad, PhD | |
Principal Investigator: Fridoon Jawad Ahmad, PhD | |
Sub-Investigator: Javed Akram, MBBS,FRCS,MRCP | |
Sub-Investigator: Riffat Mehboob, PhD | |
Sub-Investigator: Syed Amir Gilani, PhD | |
Sub-Investigator: Muhammad Akram Tariq, PhD | |
Sub-Investigator: Gibran Sheikh, PhD | |
Sub-Investigator: Hassan Ahmad Khan, M.Phil |
Study Chair: | Javed Akram, MBBS,FRCP,MRCP | Saglik Bilimleri Universitesi | |
Principal Investigator: | Fridoon J Ahmad, Ph.D | Saglik Bilimleri Universitesi |
Responsible Party: | Prof. Dr. Fridoon Jawad Ahmad, Professor,, University of Health Sciences Lahore |
ClinicalTrials.gov Identifier: | NCT04548557 |
Other Study ID Numbers: |
UniversityHSL-IVIG |
First Posted: | September 14, 2020 Key Record Dates |
Last Update Posted: | September 14, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Covid 19 intravenous immunogloulin therapy passive immunization |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Immunoglobulins Immunoglobulins, Intravenous Antibodies gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |