COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04293887

Jianping Zhao, Ph.D.

Zhaojp88@126.com

2020-03-03

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: age ≥ 18 years; clinically diagnosed patients with new type of coronavirus pneumonia, including: in accordance with the criteria for suspected cases, have one of the following etiology evidence: ① real-time fluorescence rt-pcr of respiratory specimens or blood specimens for detection of new coronavirus nucleic acid; ② sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronavirus the time interval between the onset of symptoms and random enrollment is within 7 days. the onset of symptoms is mainly based on fever. if there is no fever, cough, diarrhea or other related symptoms can be used.

any situation where the programme cannot be carried out safely; patients who have used interferon or remedesivir; no clinical manifestations and chest imaging findings known allergy or hypersensitivity to interferon (including asthma); disabled in patients with uncontrolled autoimmune diseases; patients with severe heart disease, decompensated liver disease, renal insufficiency (crcl <50ml / min), and those with abnormal bone marrow function are prohibited; epilepsy and impaired central nervous system function; pregnancy: positive pregnancy test for women of childbearing age; breastfeeding women have not stopped breastfeeding; the patient may be transferred to a non-participating hospital within 72 hours.

2

Tongji Hospital

18

None

None

Mild disease at enrollment

1: Mild disease at enrollment

328

The incidence of side effects;The incidence of side effects;The incidence of side effects

None

Phase 1

[{"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"}]