COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50470

Huilan Zhang

huilanz_76@163.com

2020-03-03

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Aged >=18 years, 2. Clinically diagnosed patients with COVID-19, including: on the basis of meeting the criteria for suspected cases, one of the following etiology evidence: (1) real-time fluorescent RT-PCR detection of SARS-Cov-2 nucleic acid samples in respiratory or blood samples, (2) Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known SARS-Cov-2, 3. The interval between the onset of symptoms and random enrollment is within 7 days. The onset of symptoms is mainly based on fever. Cough, diarrhea or other related symptoms can be used for the evidence of onset symptoms if without fever.

1. Any situation where the programme cannot be carried out safely, 2. Patients who have used interferon or remedesivir, 3. No clinical manifestations and chest imaging findings, 4. Known allergy or hypersensitivity to interferon (including asthma), 5. Disabled in patients with uncontrolled autoimmune diseases, 6. Patients with severe heart disease, decompensated liver disease, renal insufficiency (CrCL <50ml / min), and those with abnormal bone marrow function are prohibited, 7. Epilepsy and impaired central nervous system function, 8. Pregnancy: Positive pregnancy test for women of childbearing age, 9. Breastfeeding women have not stopped breastfeeding, 10. The patient may be transferred to a non-participating hospital within 72 hours.

2

Department of Respiratory and Critical Care Medicine; Tongji Hospital of Tongji Medical College; Huazhong University of Science and Technology

18

110

China

Mild disease at enrollment

1: Mild disease at enrollment

328

Incidence of side effects;

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

Phase 4

[{"arm_notes": "", "treatment_id": 665, "treatment_name": "Interferon alpha1b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]