NCT04268537

Immunoregulatory Therapy for 2019-nCoV

Status unknown Phase 2 Last updated 13 February 2020

What this trial tests

Phase 2 trial testing PD-1 blocking antibody+standard treatment in 2019 nCoV, PD-1 in 120 participants. Status unknown.

Timeline

10 February 2020

Primary endpoint
30 April 2020

31 October 2020

Quick facts

Lead sponsor	Southeast University, China
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	10 February 2020
Primary completion	30 April 2020
Estimated completion	31 October 2020

Drugs / interventions tested

• PD-1 blocking antibody+standard treatment — full drug profile →
• Thymosin+standard treatment — full drug profile →
• standard treatment

Conditions studied

• 2019 nCoV, PD-1 — all drugs for 2019 nCoV, PD-1 →

Sponsor

Southeast University, China

Who can join

18 and older, any sex, with 2019 nCoV, PD-1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sepsis, including viral infections, are major causes of death worldwide. Studies show that in 2017, the number of sepsis patients worldwide reached as high as 48.9 million, of which 11 million patients died. Studies in China also showed that more than 1 million patients died of sepsis in 2015. Previous studies have suggested that sepsis are often secondary to excessive inflammatory response syndrome. However, treatment measures targeting excessive inflammatory response failed to effectively improve the prognosis of patients. PD-1 and PD-L1 are key mediators in T cell depletion in sepsis patients. Therefore, the investigators try to performe a clinical research to investigate the efficacy of PD-1 and thymosin in patients with severe pneumonia associated with lymphocytopenia in 2019 novel coronavirus infection.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
2. Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
   Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006
3. Immune-mediated approaches against COVID-19.
   Florindo HF, Kleiner R, Vaskovich-Koubi D, Acúrcio RC, et al · · 2020 · cited 219× · PMID 32661375 · DOI 10.1038/s41565-020-0732-3
4. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
5. T-cell responses and therapies against SARS-CoV-2 infection.
   Toor SM, Saleh R, Sasidharan Nair V, Taha RZ, et al · · 2021 · cited 158× · PMID 32935333 · DOI 10.1111/imm.13262
6. Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
   Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
7. FDA approved drugs with pharmacotherapeutic potential for SARS-CoV-2 (COVID-19) therapy.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2020 · cited 105× · PMID 32717568 · DOI 10.1016/j.drup.2020.100719
8. Harnessing the immune system to overcome cytokine storm and reduce viral load in COVID-19: a review of the phases of illness and therapeutic agents.
   Khadke S, Ahmed N, Ahmed N, Ratts R, et al · · 2020 · cited 69× · PMID 33059711 · DOI 10.1186/s12985-020-01415-w