COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000322-En

Consuelo Macias Abraham

cmabraham@infomed.sld.cu

2020-07-03

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Long covid

1. Patient who gives his informed consent. 2. Negative viral load by PCR. 3. Over 18 and under 75. 4. Lung damage evidenced by the criteria of radiological severity in COVID 19 on CT.

1. Anemia2. Patients with contraindications to the use of IOR® LEUKOCIM.3. Patients who have taken amiodarone in the last 3 months, which can cause pulmonary fibrosis.4. Patients with malignant tumor in the last 5 years.5. Patients with decompensated heart and kidney disease.6. Patients with liver disease whose presence of enzyme values 2 times above the upper level of the range of normal values is demonstrated in the blood chemistry.7. Patients who have ultrasound images that require further study for diagnosis.8. Pregnant women 9. Patients with severe lung infection who need anti-infective treatment.10. Patients with proven viral infections or positive serology.

2

Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”

19

74

Cuba

Patients recovered from covid

N/A

20

Reduction of the lung lesions (They will evaluate by images of the Chest Computed Tomography. In which it is measured through a lung damage assessment scale consisting of: a. No injury (0 points); b. Unilateral lesion with less than three lesions of any type or without expression of lesions in all lung lobes a + b (1 point); c. Unilateral lesion with more than three injuries of any type or involvement of all the lung lobes (2 points); d. Bilateral lung lesions b + b (2 points) b + c (4 points) and c + c (6 points); e. Add one more point if there are lesions in all the lobes between both lungs and f. Add an additional point if there is lung consolidation (bacterial pneumonia or clothing); lymphadenopathy or pleural effusion. The value is between 0 (normal) and 8 (maximum possible involvement). The scale will allow quantifying in percentage the results of the improvement or not of the lung lesions; classifying them as improvement; stabilization or worsening). Measurement time: at baseline and; a month and six months after treatment.

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 510, "treatment_name": "Filgrastim", "treatment_type": "Csf", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1021, "treatment_name": "Prednisone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]