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Coronavirus InfectionsNCT04327349

Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

A study testing Convalescent Plasma in people with Coronavirus Infections, run by Mazandaran University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Coronavirus Infections
What is being tested?
Convalescent Plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIran
Study dates
28 Mar 2020to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recipient:
  • COVID-19 Patients
  • Consent to attend the study
  • Age 30 to 70 years
  • Don't be intubated
  • PaO2 / FiO2 is above 200 or Spo2 is greater than 85%.
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  • Donator:
  • Complete recovery from severe COVID-19 disease and hospital discharge
  • Consent to donate blood to the infected person
  • Age 30 to 60 years
  • Has normal CBC test results
  • Negative COVID-19 RT-PCR test

Who cannot join

  • Recipient:
  • A history of hypersensitivity to blood transfusions or its products
  • History of IgA deficiency
  • Heart failure or any other factor that prevents the transmission of of 500 ml plasma
  • Entering the intubation stage
  • Donator:
Show all 11Show fewer
  • Patients infected with blood-borne viral / infectious diseases
  • Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.
  • Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)
  • Use of different drugs
  • Other prohibited donations based on blood transfusion standards

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Imam Khomeini Hospital, Mazandaran University of Medical Sciences

    Sari, Mazandaran, 4816633131

Other trials in Iran

About this study

Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial

Being tested
Convalescent Plasma
Keywords
Coronavirus, COVID-19, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Convalescent PlasmaBiological

    Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU

Study groups in NCT04327349
Study groupRoleWhat they receive
COVID-19 PatientsOtherNot described
Receives: Biological: Convalescent Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality changes in day 10

    Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

    Measured: 10 days after plasma transmission

  2. Mortality changes in day 30

    Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

    Measured: 30 days after plasma transmission

  3. Changes of C-reactive protein

    Measurement of CRP

    Measured: Day 1

  4. Changes of C-reactive protein

    Measurement of CRP

    Measured: Day 3

  5. Changes of C-reactive protein

    Measurement of CRP

    Measured: Day 7

  6. Changes of Interleukin 6

    Measurement of IL-6

    Measured: Day 1

  7. Changes of Interleukin 6

    Measurement of IL-6

    Measured: Day 3

  8. Changes of Interleukin 6

    Measurement of IL-6

    Measured: Day 7

  9. Changes of tumor necrosis factor-α

    Measurement of TNF-α

    Measured: Day 1

  10. Changes of tumor necrosis factor-α

    Measurement of TNF-α

    Measured: Day 3

  11. Changes of tumor necrosis factor-α

    Measurement of TNF-α

    Measured: Day 7

  12. Changes of PaO2/FiO2 Ratio

    Partial pressure of arterial oxygen/Percentage of inspired oxygen

    Measured: Day 1

  13. Changes of PaO2/FiO2 Ratio

    Partial pressure of arterial oxygen/Percentage of inspired oxygen

    Measured: Day 3

  14. Changes of PaO2/FiO2 Ratio

    Partial pressure of arterial oxygen/Percentage of inspired oxygen

    Measured: Day 7

Secondary outcomes (43)

  1. Changes of CD3

    Measured: Day 1

  2. Changes of CD3

    Measured: Day 3

  3. Changes of CD3

    Measured: Day 7

  4. Changes of CD4

    Measured: Day 1

  5. Changes of CD4

    Measured: Day 3

  6. Changes of CD4

    Measured: Day 7

  7. Changes of CD8

    Measured: Day 1

  8. Changes of CD8

    Measured: Day 3

  9. Changes of CD8

    Measured: Day 7

  10. Changes of CD4/CD8 ratio

    Measured: Day 1

  11. Changes of CD4/CD8 ratio

    Measured: Day 3

  12. Changes of CD4/CD8 ratio

    Measured: Day 7

  13. Changes of lymphocyte count

    Measured: Day 1

  14. Changes of lymphocyte count

    Measured: Day 3

  15. Changes of lymphocyte count

    Measured: Day 7

  16. Changes of leukocyte count

    Measured: Day 1

  17. Changes of leukocyte count

    Measured: Day 3

  18. Changes of leukocyte count

    Measured: Day 7

  19. Changes of alanine transaminase (ALT)

    Measured: Day 1

  20. Changes of alanine transaminase (ALT)

    Measured: Day 3

  21. Changes of alanine transaminase (ALT)

    Measured: Day 7

  22. Changes of aspartate transaminase (AST)

    Measured: Day 1

  23. Changes of aspartate transaminase (AST)

    Measured: Day 3

  24. Changes of aspartate transaminase (AST)

    Measured: Day 7

  25. Changes of alkaline phosphatase (ALP)

    Measured: Day 1

  26. Changes of alkaline phosphatase (ALP)

    Measured: Day 3

  27. Changes of alkaline phosphatase (ALP)

    Measured: Day 7

  28. Changes of lactate dehydrogenase (LDH)

    Measured: Day 1

  29. Changes of lactate dehydrogenase (LDH)

    Measured: Day 3

  30. Changes of lactate dehydrogenase (LDH)

    Measured: Day 7

  31. Changes of creatine phosphokinase (CPK)

    Measured: Day 1

  32. Changes of creatine phosphokinase (CPK)

    Measured: Day 3

  33. Changes of creatine phosphokinase (CPK)

    Measured: Day 7

  34. Changes of Creatine kinase-MB (CK-MB)

    Measured: Day 1

  35. Changes of Creatine kinase-MB (CK-MB)

    Measured: Day 3

  36. Changes of Creatine kinase-MB (CK-MB)

    Measured: Day 7

  37. Changes of Specific IgG

    Measured: Day 1

  38. Changes of Specific IgG

    Measured: Day 3

  39. Changes of Specific IgG

    Measured: Day 7

  40. Radiological findings

    Computed tomography Scan and Chest X-Ray

    Measured: Within 2 hours after admission

  41. Radiological findings

    Computed tomography Scan and Chest X-Ray

    Measured: Day 14

  42. Number of days ventilated

    Measured: Through study completion, an average of 2 weeks

  43. Length of hospitalization

    Measured: Through study completion, an average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2020
  2. Study start28 Mar 2020 (estimated)
  3. Primary completion20 May 2020 (estimated)
  4. Study completion30 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327349
Sponsor's protocol ID
IR.MAZUMS.REC.1399.7330
Other IDs
IRCT20181104041551N1
Status last verified
Mar 2020
First submitted
24 Mar 2020
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Convalescent Plasma in people with Coronavirus Infections, run by Mazandaran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality changes in day 10 (time frame: 10 days after plasma transmission). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04327349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

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