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

COVID-19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376788
• Other study ID #: FMASU P22/2020
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: Mohamed M Moussa, MD
• Phone: +201001553744
• Email: drmohamed_metwali1[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Adult patients are 18 years old or above.

2. Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria.

3. CT chest with extensive lung disease (ground-glass and consolidative pulmonary opacities).

4. O2 saturation less than 93% resting.

5. Respiratory rate equal or more than 30 per minute.

Exclusion Criteria:

1. Patients with pregnancy and lactation.

2. Renal failure and heart failure.

3. Contraindication for plasma or blood transfusion.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• exchange blood transfusion from normal donor
IV method
• plasma from convalescent patients with COVID-19
IV method

Drug:
• Methylene Blue 5 MG/ML
IV method

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Chang, 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 Feb 7. doi: 10.1001/jama.2020.1623. [Epub ahead of print] — View Citation

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, Wölfel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	three to five days days
Secondary	change in organs function with PFS and OS	change in the liver , kidney function and change in ferritin level with normal D Dimer	0ne month