AzTrials
AzTrials

COVID-19Phase 2COVID-19NCT04376788

Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19

A Phase 2 study testing exchange blood transfusion from normal donor, plasma from convalescent patients with COVID-19 and Methylene Blue 5 MG/ML in people with COVID-19, run by Ain Shams University at 1 site in Egypt.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19
What is being tested?
exchange blood transfusion from normal donor, plasma from convalescent patients with COVID-19 and Methylene Blue 5 MG/ML
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteEgypt
Study dates
20 May 2020to 1 Sep 2020
Phase
Phase 2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients are 18 years old or above.
  • Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria.
  • CT chest with extensive lung disease (ground-glass and consolidative pulmonary opacities).
  • O2 saturation less than 93% resting.
  • Respiratory rate equal or more than 30 per minute.

Who cannot join

  • Patients with pregnancy and lactation.
  • Renal failure and heart failure.
  • Contraindication for plasma or blood transfusion.

Trial locations and contacts

1 site in 1 country.

Mohamed M Moussa, MD contact

+201001553744

drmohamed_metwali1@med.asu.edu.eg

Essam A Hassan, MD contact

+201001839394

essam.abdelwahed@yahoo.com

Egypt1 site, 1 recruiting

  • Ain Shams University

    Cairo, 11556

    Mohamed M Moussa, MD, +201001839394, drmohamed_metwali1@med.asu.edu.eg

    Essam A Hassan, MD, +201001939394, essam.abdelwahed@yahoo.com

    Recruiting

Other trials in Egypt

About this study

The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.

Read the detailed description

Study Tools AND/ OR procedure

The patients were subjected to the following:

Clinical parameters:

Complete history taking and thorough clinical examination

  1. Laboratory parameters:
  2. CBC with differential counts.
  3. Reticulocytic count.
  4. Blood film for shistocytes.
  5. Serum ferritin and transferrin saturation.
  6. D dimer.
  7. Liver function tests, kidney function tests, electrolytes.
  8. ESR.
  9. CRP.
  10. LDH.
  11. Viral markers (HCV Ab, HBsV AG, HIV Ab).
  12. ADAM'S 13 assays.
  13. Serum soluble CD 25.

Other investigations:

  1. Chest X ray.
  2. Pelviabdominal US.
  3. CT chest.
  4. ECG.
  5. Echocardiography

The patients will be divided into three groups, each group formed of 5 patients with severe COVID-19 or on mechanical ventilator receiving standard of care All the groups matched regarding age, sex and the severity of the disease.

Group I:

Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs daily for 3 days according to daily clinical and investigational follow up

Group II Will receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.

Group III Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.

N.B.: Convalescent plasma and regular blood will be taken from ministry of health after administrative approval All groups will receive

  1. Low dose anticoagulant (LMWH 1 mg/kg/day).
  2. Steroid (methyl prednisone 1 mg/ kg IV daily and according to patients' condition and presence of complications like hemophagocytosis).
  3. All allergic precautions if needed like antihistaminics , epinephrine and steroid.

Close monitoring for:

  1. Allergic reactions.
  2. ECG changes daily.
  3. Volume overload.
  4. Complications of other comorbidities like DM or HTN.
  5. Liver function and kidney function and organ dysfunction daily.

Terms of discontinuation:

Deterioration of clinical condition or organ functions.

Conditions
COVID-19
Being tested
exchange blood transfusion from normal donor, plasma from convalescent patients with COVID-19, Methylene Blue 5 MG/ML
Keywords
COVID-19, Exchange transfusion, Methylene blue
Medical subject headings
COVID-19

What participants receive

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

  • exchange blood transfusion from normal donorBiological

    IV method

  • plasma from convalescent patients with COVID-19Biological

    IV method

  • Methylene Blue 5 MG/MLDrug

    IV method

Study groups in NCT04376788
Study groupRoleWhat they receive
Exchange transfusionExperimentalWill receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs daily for 3 days according to daily clinical and investigational follow up
Receives: Biological: exchange blood transfusion from normal donor
Methylene blue with plasmaExperimentalWill receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
Receives: Biological: plasma from convalescent patients with COVID-19; Drug: Methylene Blue 5 MG/ML
Exchange transfusion and methylene blue with plasmaExperimentalWill receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
Receives: Biological: exchange blood transfusion from normal donor; Biological: plasma from convalescent patients with COVID-19; Drug: Methylene Blue 5 MG/ML

What is being measured

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

  1. improvement of condition

    improvement of general condition of the patients as the ventilator parameters and serum level of ferritin , D dimer, CBC, oxygen level in blood and patient o2 saturation

    Measured: three to five days days

Secondary outcomes (1)

  1. change in organs function with PFS and OS

    change in the liver , kidney function and change in ferritin level with normal D Dimer

    Measured: 0ne month

Timeline

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

  1. First posted6 May 2020
  2. Study start20 May 2020
  3. Primary completion1 Jul 2020 (estimated)
  4. Study completion1 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group I: Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs daily for 3 days according to daily clinical and investigational follow up Group II Will receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up. Group III Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04376788
Sponsor's protocol ID
FMASU P22/2020
Acronym
COVID-19
Status last verified
Jul 2020
First submitted
1 May 2020
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chang D, Lin M, Wei L, Xie L, Zhu G, Dela Cruz CS, Sharma L. Epidemiologic and Clinical Characteristics of Novel Coronavirus Infections Involving 13 Patients Outside Wuhan, China. JAMA. 2020 Mar 17;323(11):1092-1093. doi: 10.1001/jama.2020.1623.

    PubMed 32031568

  • Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.

    PubMed 32003551

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exchange blood transfusion from normal donor, plasma from convalescent patients with COVID-19 and Methylene Blue 5 MG/ML in people with COVID-19, run by Ain Shams University at 1 site in Egypt.

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 5 inclusion and 3 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 9 Jul 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 Egypt. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Mohamed M Moussa, MD (+201001553744, drmohamed_metwali1@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement of condition (time frame: three to five days days). 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 NCT04376788, which also lists 2 linked publications.

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 9 Jul 2020.

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