COVID-19 Pipeline: Introduction
- The coronavirus outbreak is at a tipping point, after which its development into a global pandemic may be inevitable
- Research & development efforts by various players operating in the global COVID-19 space are now underway to investigate and develop a range of established and novel drug platforms, including prophylactic vaccines, repurposed medicines, and treatments against the virus, known as SARS-CoV-2
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- The World Health Organization is working with a number of research organizations to conduct clinical trials of existing antiviral drugs to treat patients suffering from COVID-19. For instance, the World Health Organization is collaborating with researchers in China to conduct rapid clinical trials of existing antiviral medications to treat patients infected with COVID-19.
- On February 20, 2020, it was announced that trials have been launched in China to determine the efficacy and safety of two existing antiviral therapies: Gilead Sciences, Inc.’s nucleotide analog remdesivir, which was already under development for Ebola, and AbbVie, Inc.’s HIV combination therapy Kaletra (the combination of lopinavir and ritonavir).
Below Table Represents the COVID-19 Development Pipeline as of April 2020
| NCT Number | NCT04276987 |
| Conditions | Coronavirus |
| Interventions | Biological: MSCs-derived exosomes |
| Sponsor / Collaborators | Ruijin Hospital, Shanghai Public Health Clinical Center, Wuhan Jinyintan Hospital, Wuhan, Chin, Cellular Biomedicine Group Ltd. |
| Phase / Enrollment / Completion Date | Phase 1 / 30 / July 31, 2020 |
| NCT Number | NCT04317040 |
| Conditions | Severe Coronavirus Disease (COVID-19) |
| Interventions | Drug: CD24Fc | Drug: Placebo |
| Sponsor / Collaborators | OncoImmune, Inc. |
| Phase / Enrollment / Completion Date | Phase 3 / 230 / May, 2022 |
| NCT Number | NCT04336410 |
| Conditions | Coronavirus Infection |
| Interventions | Drug: INO-4800 | Device: CELLECTRAÂ 2000 |
| Sponsor / Collaborators | Inovio Pharmaceuticals, Coalition for Epidemic Preparedness Innovations (CEPI) |
| Phase / Enrollment / Completion Date | Phase 1 / 40 / November, 2020 |
| NCT Number | NCT04333472 |
| Conditions | COVID-19 | Coronavirus Infection |
| Interventions | Drug: Piclidenoson |
| Sponsor / Collaborators | Can-Fite BioPharma, Rabin Medical Center |
| Phase / Enrollment / Completion Date | Phase 2 / 40 / July 6, 2020 |
| NCT Number | NCT04334928 |
| Conditions | Coronavirus Infection |
| Interventions | Drug: Emtricitabine / tenofovir disoproxil | Drug: Hydroxychloroquine | Drug: Placebo: Emtricitabine / tenofovir disoproxil Placebo | Drug: Placebo: Hydroxychloroquine |
| Sponsor / Collaborators | Plan Nacional sobre el Sida Servicios Para la Investigacion S.L. |
| Phase / Enrollment / Completion Date | Phase 3 / 4000 / July 31, 2020 |
| NCT Number | NCT04322123 |
| Conditions | Coronavirus Infections |
| Interventions | Drug: Hydroxychloroquine Oral Product | Drug: Hydroxychloroquine + azithromycin |
| Sponsor / Collaborators | Hospital do Coracao, Hospital Israelita Albert Einstein, Hospital Sirio-Libanes, Brazilian Research In Intensive Care Network, EMS |
| Phase / Enrollment / Completion Date | Phase 3 / 630 / August 30, 2020 |
| NCT Number | NCT04326426 |
| Conditions | Coronavirus Infection |
| Interventions | Drug: Tradipitant | Drug: Placebo |
| Sponsor / Collaborators | Vanda Pharmaceuticals |
| Phase / Enrollment / Completion Date | Phase 3 / 300 / August 31, 2020 |
| NCT Number | NCT04291729 |
| Conditions | 2019-nCoV Pneumonia |
| Interventions | Drug: Ganovo+ritonavir+ / -Interferon nebulization |
| Sponsor / Collaborators | The Ninth Hospital of Nanchang, Ascletis Pharmaceuticals Co., Ltd. |
| Phase / Enrollment / Completion Date | Phase 4 / 11 / March 19, 2020 |
| NCT Number | NCT04299152 |
| Conditions | Severe Acute Respiratory Syndrome (SARS) Pneumonia |
| Interventions | Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis |
| Sponsor / Collaborators | Tianhe Stem Cell Biotechnologies Inc. |
| Phase / Enrollment / Completion Date | Phase 2 / 20 / November 10, 2020 |
| NCT Number | NCT04315896 |
| Conditions | COVID-19 | Severe Acute Respiratory Syndrome |
| Interventions | Drug: Hydroxychloroquine | Drug: Placebo oral tablet |
| Sponsor / Collaborators | National Institute of Respiratory Diseases, Mexico | Sanofi |
| Phase / Enrollment / Completion Date | Phase 3 / 500 / March 22, 2021 |
| NCT Number | NCT04321278 |
| Conditions | Coronavirus Infections | Pneumonia, Viral |
| Interventions | Drug: Hydroxychloroquine + azithromycin | Drug: Hydroxychloroquine |
| Sponsor / Collaborators | Hospital Israelita Albert Einstein, EMS, Hospital do Coracao, Hospital Sirio-Libanes, Brazilian Research In Intensive Care Network, Cristália Produtos QuÃmicos Farmacà uticos Ltda. |
| Phase / Enrollment / Completion Date | Phase 3 / 440 / August 30, 2020 |
| NCT Number | NCT04292730 |
| Conditions | COVID-19 |
| Interventions | Drug: Remdesivir | Drug: Standard of Care |
| Sponsor / Collaborators | Gilead Sciences |
| Phase / Enrollment / Completion Date | Phase 3 / 600 / May, 2020 |
| NCT Number | NCT04302519 |
| Conditions | COVID-19 |
| Interventions | Biological: Dental pulp mesenchymal stem cells |
| Sponsor / Collaborators | CAR-T (Shanghai) Biotechnology Co., Ltd. |
| Phase / Enrollment / Completion Date | Early Phase 1 / 24 / July 30, 2021 |
| NCT Number | NCT04327401 |
| Conditions | Coronavirus Infection | Pneumonia, Viral | Acute Respiratory Distress Syndrome |
| Interventions | Drug: Dexamethasone |
| Sponsor / Collaborators | Luiz F. L. Reis, Ph.D., Hospital Israelita Albert Einstein, Hospital do Coracao, Brazilian Research In Intensive Care Network, Ache Laboratorios Farmaceuticos S.A., Hospital Sirio-Libanes |
| Phase / Enrollment / Completion Date | Phase 3 / 290 / August 30, 2020 |
| NCT Number | NCT03331445 |
| Conditions | Respiratory Tract Infections | Corona Virus Infection |
| Interventions | Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation |
| Sponsor / Collaborators | University of British Columbia | Mallinckrodt |
| Phase / Enrollment / Completion Date | Phase 2 / 20 / March 31, 2021 |
| NCT Number | NCT04311697 |
| Conditions | Acute Respiratory Distress Syndrome | Acute Lung Injury / Acute Respiratory Distress Syndrome (ARDS) | Corona Virus Infection |
| Interventions | Drug: Aviptadil by intravenous infusion + maximal intensive care | Drug: Normal Saline Infusion + Maximal intensive care |
| Sponsor / Collaborators | NeuroRx, Inc., Relief Therapeutics Holding SA, Target Health Inc., Lavin Consulting, LLC |
| Phase / Enrollment / Completion Date | Phase 2 / 120 / September, 2020 |
| NCT Number | NCT04333420 |
| Conditions | COVID-19 Pneumonia |
| Interventions | Drug: Best supportive Care (BSC) + IFX-1 | Drug: Best supportive care only |
| Sponsor / Collaborators | InflaRx GmbH |
| Phase / Enrollment / Completion Date | Phase 2 | Phase 3 / 130 / December 31, 2020 |
| NCT Number | NCT04315298 |
| Conditions | COVID-19 |
| Interventions | Drug: Sarilumab | Drug: Placebo |
| Sponsor / Collaborators | Regeneron Pharmaceuticals | Sanofi |
| Phase / Enrollment / Completion Date | Phase 2 | Phase 3 / 400 / April 01, 2021 |
| NCT Number | NCT04328285 |
| Conditions | COVID-19 |
| Interventions | Drug: Hydroxychloroquine | Drug: Placebo of Hydroxychloroquine | Drug: Lopinavir and ritonavir | Drug: Placebo of LPV / r Tablets |
| Sponsor / Collaborators | Centre Hospitalier Universitaire de Saint Etienne, Institut Pasteur |
| Phase / Enrollment / Completion Date | Phase 3 / 1200 / November 30, 2020 |
| NCT Number | NCT04330690 |
| Conditions | COVID-19 |
| Interventions | Drug: Lopinavir / ritonavir |
| Sponsor / Collaborators | Sunnybrook Health Sciences Centre, AbbVie |
| Phase / Enrollment / Completion Date | Phase 2 / 440 / May 18, 2022 |
| NCT Number | NCT04335136 |
| Conditions | COVID-19 |
| Interventions | Drug: RhACE2 APN01 | Drug: Physiological saline solution |
| Sponsor / Collaborators | Apeiron Biologics |
| Phase / Enrollment / Completion Date | Phase 2 / 200 / November, 2020 |
| NCT Number | NCT04313023 |
| Conditions | COVID-19 |
| Interventions | Drug: PUL-042 Inhalation Solution | Drug: Placebo |
| Sponsor / Collaborators | Pulmotect, Inc. |
| Phase / Enrollment / Completion Date | Phase 2 / 200 / October, 2020 |
| NCT Number | NCT04313127 |
| Conditions | COVID-19 |
| Interventions | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Sponsor / Collaborators | CanSino Biologics Inc., Institute of Biotechnology, Academy of Military Medical Sciences. PLA of China, Jiangsu Province Centers for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Tongji Hospital |
| Phase / Enrollment / Completion Date | Phase 1 / 108 / December 20, 2022 |
| NCT Number | NCT04334980 |
| Conditions | COVID-19 |
| Interventions | Biological: bacTRL-Spike |
| Sponsor / Collaborators | Symvivo Corporation |
| Phase / Enrollment / Completion Date | Phase 1 / 84 / December 31, 2021 |
| NCT Number | NCT04329572 |
| Conditions | COVID-19 |
| Interventions | Drug: Hydroxychloroquine Sulfate | Drug: Azithromycin Tablets |
| Sponsor / Collaborators | Azidus Brasil, PREVENT SENIOR PRIVATE OPERADORA DE SAÚDE LTDA |
| Phase / Enrollment / Completion Date | Early Phase 1 / 400 / June 30, 2020 |
| NCT Number | NCT04315987 |
| Conditions | COVID-19 Pneumonia |
| Interventions | Biological: NestCell® |
| Sponsor / Collaborators | Azidus Brasil, Cellavita Pesquisa CientÃfica Ltda, Hospital Vera Cruz |
| Phase / Enrollment / Completion Date | Phase 1 / 66 / June, 2020 |
| NCT Number | NCT04320615 |
| Conditions | COVID-19 Pneumonia |
| Interventions | Drug: Tocilizumab (TCZ) | Drug: Placebo |
| Sponsor / Collaborators | Hoffmann-La Roche |
| Phase / Enrollment / Completion Date | Phase 3 / 330 / September 30, 2021 |
| NCT Number | NCT04334460 |
| Conditions | Sars-CoV2 |
| Interventions | Drug: BLD-2660 |
| Sponsor / Collaborators | Blade Therapeutics |
| Phase / Enrollment / Completion Date | Phase 2 / 120 / September, 2020 |
| NCT Number | NCT04324021 |
| Conditions | SARS-CoV-2 |
| Interventions | Biological: Emapalumab | Biological: Anakinra |
| Sponsor / Collaborators | Swedish Orphan Biovitrum |
| Phase / Enrollment / Completion Date | Phase 2 | Phase 3 / 54 / September, 2020 |
| NCT Number | NCT04335032 |
| Conditions | SARS-CoV-2 |
| Interventions | Drug: Eicosapentaenoic acid gastro-resistant capsules |
| Sponsor / Collaborators | S.L.A. Pharma AG |
| Phase / Enrollment / Completion Date | Phase 3 / 150 / July 31, 2020 |
| NCT Number | NCT03808922 |
| Conditions | Lower Respiratory Tract Infection | Parainfluenza | Immunocompromised | COVID-19 |
| Interventions | Drug: DAS181 | Drug: Placebo | Drug: DAS181 COVID-19 | Drug: DAS181 OL |
| Sponsor / Collaborators | Ansun Biopharma, Inc. |
| Phase / Enrollment / Completion Date | Phase 3 / 250 / December 28, 2021 |
- Global pharma companies such as Gilead Sciences, Inc., Sanofi, and Vanda Pharmaceuticals are developing a treatment regimen for COVID-19
- On March 24, 2020, Gilead Sciences, Inc.’s experimental drug remdesivir received orphan drug designation from the U.S. Food and Drug Administration. The drug is considered one of the potential coronavirus treatments.
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- The drug has received seven years of marketing exclusivity with the orphan drug status. According to the company’s Chairman and Chief Executive Officer Daniel O’Day, the drug will offer expanded access, compassionate use, and will treat patients with severe symptoms.
- The company has also planned to increase the supply of the drug to more than 500,000 treatment courses by October and over 1 million treatment courses by the end of the year
- Moreover, a Cambridge biotech company, Moderna has developed a coronavirus vaccine using a novel technology called messenger RNA (mRNA). The vaccine has been made ready in just 42 days for testing on humans. It is the first company to reach this stage of development.
- A number of other drug developers are accelerating their programs for COVID-19 treatment. Inovio Pharmaceuticals, Inc. is developing the vaccine INO-4800 for the treatment of COVID-19. The company aims to produce 1 million doses of the INO-4800 vaccine by the end of the year to perform additional clinical trials and / or emergency use of the vaccine.
- GSK has partnered with Clover Corp. Ltd., a China-based firm, to develop a novel protein-based COVID-19 S-Trimer vaccine. The vaccine is being developed by Clover Corp. GSK will provide Clover Corp. its pandemic adjuvant system to evaluate the drug in preclinical studies. Meanwhile, Clover Corp. is organizing its cGMP facilities in China for scale-up and mass production of the vaccine.
- Sanofi and Regeneron Pharmaceuticals, Inc. are evaluating Sanofi’s Kevzara, (a drug used in the treatment of rheumatoid arthritis) for the treatment of the symptoms related to the coronavirus
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- On March 16, 2020, Sanofi and Regeneron Pharmaceuticals launched a phase II / III clinical study program in the U.S. The study evaluates the drug sarilumab as a treatment for severe coronavirus infection in up to 400 patients. The drug is an interleukin-6 (IL-6) receptor antagonist and was approved by the FDA in 2017 for the treatment of moderately to severely active rheumatoid arthritis in adults, who have an intolerance or inadequate response to one or more disease-modifying anti-rheumatic drugs.
- Additionally, in February 2020, Sanofi announced that it will work with the U.S. Department of Health and Human Services (HHS) to develop coronavirus vaccine. The company’s global head of vaccine announced that the company would partner with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop the vaccine against the coronavirus using the company’s recombinant DNA platform.
- The global pandemic situation can occur at any point like coronavirus outbreak. Hence, scientists as well as pharmaceuticals and biotech companies are attempting to develop treatments and vaccines as quickly as possible to meet the increasing unmet needs of those affected.
- Companies such as Sanofi, Roche, Gilead Sciences, Moderna, and Regeneron Pharmaceuticals are taking efforts to develop treatments and vaccines as quickly as possible to serve the unmet needs across the globe
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