How did the coronavirus outbreak start?

Answer

Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China.^[1]It was initially reported to the World Health Organization (WHO) on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.^{[2, 3]}On March 11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since declaring H1N1 influenza a pandemic in 2009.^[4]

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Eculizumab (Soliris) in Covid-19 Infected Patients (SOLID-C19). ClinicialTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04288713. 2020 Mar 30;
Alexion provides update on phase 3 study of Ultomiris (ravulizumab-cwvz) in hospitalized patients with severe COVID-19. Alexion Pharmaceuticals, Inc. 2021 Jan 13. Available at https://ir.alexion.com/news-releases/news-release-details/alexion-provides-update-phase-3-study-ultomirisr-ravulizumab.
Study to evaluate the safety and efficacy of ATYR1923 in patients with severe pneumonia related to COVID-19. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04412668. 2020 Jun 04;
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients with ARDS. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT03202394?term=NCT03202394&draw=2&rank=1. 2018 Dec 06; Accessed: Apr 24, 2020.
Chimerix Announces Initiation of a Phase 2/3 Study of DSTAT in Acute Lung Injury for Patients with Severe COVID-19. Chimerix. 2020 Apr 29. Available at https://ir.chimerix.com/news-releases/news-release-details/chimerix-announces-initiation-phase-23-study-dstat-acute-lung.
A study of opaganib in coronavirus disease 2019 pneumonia (COVID-19). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04414618. 2020 Jul 31;
Opaganib, a sphingosine kinase-2 (SK2) inhibitor in COVID-19 pneumonia. ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04467840. 2020 Jul 17; Accessed: July 31, 2020.
LB1148 Now Available for Investigational Use to Treat Pulmonary Dysfunction Associated with COVID-19 Pneumonia. Leading BioSciences. 2020 May 15. Available at https://www.globenewswire.com/news-release/2020/05/15/2034269/0/en/Leading-BioSciences-Receives-IND-Clearance-for-Phase-2-COVID-19-Study.html.
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study. ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT03808922?term=DAS181&cond=COVID&draw=2&rank=4. 2020 Apr 17;
Applied Therapeutics Announces IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients. Applied Therapeutics. 2020 Apr 02. Available at https://ir.appliedtherapeutics.com/news-releases/news-release-details/applied-therapeutics-announces-ind-and-investigator-initiated.
Miller J, Bruen C, Schnaus M, Zhang J, Ali S, Lind A, et al. Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: Results from a randomized controlled trial. Research Square. 2020 Jul 15. [Full Text].
Biohaven receives FDA may proceed letter to begin phase 2 trial of intranasal vazegepant to treat lung inflammation after COVID-19 infection. Biohaven Pharmaceuticals. 2020 Apr 09. Available at https://www.biohavenpharma.com/investors/news-events/press-releases/04-09-2020.
Evaluation of activity and safety of oral selinexor in participants with severe COVID-19 infection (coronavirus). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04349098. 2020 May 08; Accessed: October 7, 2020.
Evelo Biosciences, Rutgers University, and Robert Wood Johnson University Hospital Announce Submission of IND for a Phase 2 Study of EDP1815 in COVID-19 Patients. Evelo Biosciences. 2020 May 07. Available at https://ir.evelobio.com/news-releases/news-release-details/evelo-biosciences-rutgers-university-and-robert-wood-johnson.
Evelo Biosciences announces EDP1815 to advance into phase 2/3 TACTIC-E COVID-19 trial. Evelo Biosciences. 2020 Jun 22. Available at https://ir.evelobio.com/news-releases/news-release-details/evelo-biosciences-announces-edp1815-advance-phase-23-tactic-e.
VERU-111 suppresses key cytokines responsible for severe acute respiratory distress syndrome in COVID-19. Veru, Inc. 2020 Aug 04. Available at https://verupharma.com/news/veru-111-suppresses-key-cytokines-responsible-for-severe-acute-respiratory-distress-syndrome-in-covid-19/.
Q BioMed partner Mannin Research developing potential treatment for patients infected with coronavirus and other infectious diseases. Q BioMed. 2020 Feb 04. Available at https://qbiomed.com/news-and-media/news-2020/180-q-biomed-partner-mannin-research-developing-potential-treatment-for-patients-infected-with-coronavirus-and-other-infectious-diseases.
Diffusion Pharmaceuticals receives FDA guidance for international phase 1b/2b COVID-19 clinical program with TSC. Diffusion Pharmaceuticals. 2020 July 27. Available at https://investors.diffusionpharma.com/News/news-details/2020/Diffusion-Pharmaceuticals-Receives-FDA-Guidance-for-International-Phase-1b2b-COVID-19-Clinical-Program-with-TSC/default.aspx.
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FDA authorizes OPKO Health clinical trial evaluating Rayaldee in COVID-19 patients. OPKO Health. 2020 Jun 01. Available at https://www.opko.com/news-media/press-releases/detail/394/fda-authorizes-opko-health-clinical-trial-evaluating.
LYT-100 in Post-acute COVID-19 Respiratory Disease. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04652518. 2020 Dec 07; Accessed: December 11, 2020.
Ashvattha Therapeutics subsidiary Orpheris announces FDA agreement to initiate phase 2 study evaluating OP-101 in severe COVID-19 patients. Ashvattha Therapeutics. 2020 May 28. Available at https://avttx.com/ashvattha-therapeutics-subsidiary-orpheris-announces-fda-agreement-to-initiate-phase-2-study-evaluating-op-101-in-severe-covid-19-patients/.
A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04379271. 2020 May 11;
Immunic, Inc. announces first patients enrolled in investigator-sponsored phase 2 clinical trial of IMU-838 in combination with oseltamivir for the treatment of patients with moderate-to-severe COVID-19. Immunic, Inc. 2020 Jul 27. Available at https://www.immunic-therapeutics.com/2020/07/27/immunic-inc-announces-first-patients-enrolled-in-investigator-sponsored-phase-2-clinical-trial-of-imu-838-in-combination-with-oseltamivir-for-the-treatment-of-patients-with-moderate-to-severe-covid-19/.
Oryzon announces enrollment of first patient in ESCAPE: a Phase II clinical trial with vafidemstat in severely ill COVID-19 patients. Oryzon Genomics. 2020 May 18. Available at https://www.oryzon.com/sites/default/files/PRESS_RELEASE_13-2020.pdf.
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Prazosin to prevent COVID-19 (PREVENT-COVID Trial). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04365257. 2020 May 15; Accessed: June 16, 2020.
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Study of Ampion for the treatment of adult COVID-19 patients requiring oxygen supplementation. ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04456452. 2020 Jul 24;
Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients. Fulcrum Therapeutics. 2020 Jun 24. Available at https://ir.fulcrumtx.com/news-releases/news-release-details/fulcrum-therapeutics-announces-initiation-multi-center-phase-3.
Durect Corporation announces initiation of patient recruitment in phase 2 safety and efficacy study of DUR-928 in COVID-19 patients with acute liver or kidney injury. Durect Corporation. 2020 Jul 01. Available at https://investors.durect.com/news-releases/news-release-details/durect-corporation-announces-initiation-patient-recruitment?field_nir_news_date_value[min]=2020.
Aclaris Therapeutics Supports Investigator-Initiated Clinical Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19. Aclaris Therapeutics. 2020 Jun 17. Available at https://investor.aclaristx.com/news-releases/news-release-details/aclaris-therapeutics-supports-investigator-initiated-clinical.
Study to evaluate the efficacy and safety of leronlimab for mild to moderate COVID-19. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04343651. 2020 Jun 11; Accessed: July 13, 2020.
Study to evaluate the efficacy and safety of leronlimab for patients with severe or critical coronavirus disease 2019 (COVID-19). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04347239. 2020 Jun 11; Accessed: July 13, 2020.
Biophytis receives FDA IND clearance for COVA, a phase 2/3 clinical trial with sarconeos (BIO101) for the treatment of patients with COVID-19 related respiratory failure. Biophytis. 2020 Jul 01. Available at https://www.biophytis.com/wp-content/uploads/2020/07/Biophytis-COVA-FDA-IND-Clearance-PR-EN-vF-.pdf.
FDA clears abivertinib for Phase 2 safety and efficacy study in hospitalized patients with moderate to severe COVID-19. Sorrento Therapeutics. 2020 July 20. Available at https://investors.sorrentotherapeutics.com/news-releases/news-release-details/fda-clears-abivertinib-phase-2-safety-and-efficacy-study.
Safety, tolerability and efficacy of nangibotide in mechanically ventilated patients with COVID-19 and features of systemic inflammation. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04429334. 2020 Jun 12; Accessed: July 23, 2020.
Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study. Can-Fite BioPharma. 2020 Jul 27. Available at https://ir.canfite.com/press-releases/detail/917/can-fite-submits-investigational-new-drug-application-to-u-s-fda-for-covid-19-phase-ii-study.
LSALT peptide vs placebo to prevent ARDS and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04402957. 2020 Jun 16; Accessed: : July 28, 2020.
ReAlta Life Sciences announces U.S. FDA clearance of first investigational new drug application for RLS-0071. ReAlta Life Sciences. 2020 Jul 28. Available at https://realtalifesciences.com/realta-life-sciences-announces-u-s-fda-clearance-of-first-investigational-new-drug-application-for-rls-0071/.
Safety and antiviral activity of BLD-2660 in COVID-19 hospitalized subjects. ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04334460. 2020 Sep 03; Accessed: September 15, 2020.
Enzychem Lifesciences announces FDA acceptance of phase 2 study of EC-18 in preventing acute respiratory distress Syndrome (ARDS) due to COVID-19 pneumonia. Enzychem Lifesciences. 2020 Aug 14. Available at https://www.enzychem.com/enzychem-lifesciences-announces-fda-acceptance-of-phase-2-study-of-ec-18-in-preventing-acute-respiratory-distress-syndrome-ards-due-to-covid-19-pneumonia/.
A study of cell therapy in COVID-19 subjects with acute kidney injury who are receiving renal replacement therapy. ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04445220. 2020 Aug 13; Accessed: August 19, 2020.
BCG Vaccine for Health Care Workers as Defense Against COVID 19 (BADAS). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04348370. 2020 May 27; Accessed: August 19, 2020.
Synthetic cannabinoid drug for COVID-19 approved for phase 1 clinical trials. Forbes. 2020 Aug 20. Available at https://www.forbes.com/sites/emilyearlenbaugh/2020/08/20/synthetic-cannabinoid-drug-for-covid-19-approved-for-phase-1-clinical-trials/#7b9374223329.
Intravenous infusion of CAP-1002 in patients with COVID-19 (INSPIRE). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04623671. 2020 Nov 24; Accessed: November 25, 2020.
Study of LAU-7b for the treatment of COVID-19 disease in adults (RESOLUTION). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04417257. 2020 Jul 17; Accessed: August 26, 2020.
SPI-1005 treatment in severe COVID-19 patients. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04483973. 2020 Jul 23; Accessed: September 14, 2020.
Rigel Announces NIH/NHLBI-sponsored trial of fostamatinib in hospitalized COVID-19 patients in collaboration with Inova. Rigel Pharmaceuticals. 2020 Sep 17. Available at https://ir.rigel.com/news-events/press-releases/detail/296/rigel-announces-nihnhlbi-sponsored-trial-of-fostamatinib.
Vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with coronavirus disease 2019 (COVID-19). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04478071. 2020 Sep 10; Accessed: September 22, 2020.
FSD Pharma begins Phase 2 clinical trial to evaluate FSD201 for the treatment of hospitalized COVID-19 patients. FSD Pharma Inc. 2020 Sep 28. Available at https://www.fsdpharma.com/news/fsd-pharma-begins-phase-2-clinical-trial-to-evaluate-fsd201-for-the-treatment-of-hospitalized-covid-19-patients/.
A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + SOC vs. placebo + SOC in adult hospitalized patients with moderate to severe COVID-19. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04401475. 2020 Jul 01; Accessed: October 26, 2020.
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COVID R&D Alliance launches trial of Amgen, UCB, Takeda drugs. Reuters. 2020 Nov 30. Available at https://www.reuters.com/article/health-coronavirus-treatment-trial/covid-rd-alliance-launches-trial-of-amgen-ucb-takeda-drugs-idUSL1N2I31W4.
Hepion Pharmaceuticals announces FDA clearance of IND application for CRV431 for COVID-19. Hepion Pharmaceuticals. 2020 Dec 22. Available at https://hepionpharma.com/news/hepion-pharmaceuticals-announces-fda-clearance-of-ind-application-for-crv431-for-covi/4573734.
Study of ensifentrine or placebo delivered via pMDI in hospitalized patients with COVID-19. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04527471. 2020 Dec 14; Accessed: January 14, 2021.
Tiziana Life Sciences Announces an Expedited Clinical Development Plan for Its Anti-Interleukin-6-Receptor, a Fully Human Monoclonal Antibody, for the Treatment of COVID-19 Patients. Tiziana Life Sciences. 2021 Aug 04. Available at https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-expedited-clinical-development-plan.
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Bucillamine in treatment of patients with COVID-19. ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04504734. 2020 Aug 07; Accessed: August 7, 2020.
CD24Fc as a nonantiviral immunomodulator in COVID-19 treatment (SAC-COVID). ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT04317040. 2020 Apr 10;
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Regeneron’s COVID-19 outpatient trial prospectively demonstrates that REGN-COV2 antibody cocktail significantly reduced virus levels and need for further medical attention. Regeneron. 2020 Oct 28. Available at https://investor.regeneron.com/news-releases/news-release-details/regenerons-covid-19-outpatient-trial-prospectively-demonstrates.
Phase 3 trial shows REGEN-COV (casirivimab with imdevimab) antibody cocktail reduced hospitalization or death by 70% in non-hospitalized COVID-19 patients. Regeneron. 2021 Mar 23. Available at https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody.
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Regeneron announces encouraging initial data from COVID-19 antibody cocktail trial in hospitalized patients on low-flow oxygen. PRNewswire. 2020 Dec 29. Available at https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-encouraging-initial-data-covid-19-antibody.
Phase 3 prevention trial showed 81% reduced risk of symptomatic SARS-CoV-2 infections with subcutaneous administration of REGEN-COV (casirivimab with imdevimab). Regeneron. 20221 Apr 12. Available at https://investor.regeneron.com/news-releases/news-release-details/phase-3-prevention-trial-showed-81-reduced-risk-symptomatic-sars.
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Media Gallery

The heart is normal in size. There are diffuse, patchy opacities throughout both lungs, which may represent multifocal viral/bacterial pneumonia versus pulmonary edema. These opacities are particularly confluent along the periphery of the right lung. There is left midlung platelike atelectasis. Obscuration of the left costophrenic angle may represent consolidation versus a pleural effusion with atelectasis. There is no pneumothorax.
The heart is normal in size. There are bilateral hazy opacities, with lower lobe predominance. These findings are consistent with multifocal/viral pneumonia. No pleural effusion or pneumothorax are seen.
The heart is normal in size. Patchy opacities are seen throughout the lung fields. Patchy areas of consolidation at the right lung base partially silhouettes the right diaphragm. There is no effusion or pneumothorax. Degenerative changes of the thoracic spine are noted.
The same patient as above 10 days later.
The trachea is in midline. The cardiomediastinal silhouette is normal in size. There are diffuse hazy reticulonodular opacities in both lungs. Differential diagnoses include viral pneumonia, multifocal bacterial pneumonia or ARDS. There is no pleural effusion or pneumothorax.
Axial chest CT demonstrates patchy ground-glass opacities with peripheral distribution.
Coronal reconstruction chest CT of the same patient above, showing patchy ground-glass opacities.
Axial chest CT shows bilateral patchy consolidations (arrows), some with peripheral ground-glass opacity. Findings are in peripheral and subpleural distribution.

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Author

David J Cennimo, MD, FAAP, FACP, FIDSA, AAHIVS Associate Professor of Medicine and Pediatrics, Adult and Pediatric Infectious Diseases, Rutgers New Jersey Medical School

David J Cennimo, MD, FAAP, FACP, FIDSA, AAHIVS is a member of the following medical societies: American Academy of HIV Medicine, American Academy of Pediatrics, American College of Physicians, American Medical Association, HIV Medicine Association, Infectious Diseases Society of America, Medical Society of New Jersey, Pediatric Infectious Diseases Society

Disclosure: Nothing to disclose.

Coauthor(s)

Scott J Bergman, PharmD, FCCP, FIDSA, BCPS, BCIDP Antimicrobial Stewardship Program Coordinator, Infectious Diseases Pharmacy Residency Program Director, Department of Pharmaceutical and Nutrition Care, Division of Infectious Diseases, Nebraska Medicine; Clinical Associate Professor, Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center

Scott J Bergman, PharmD, FCCP, FIDSA, BCPS, BCIDP is a member of the following medical societies: American Association of Colleges of Pharmacy, American College of Clinical Pharmacy, American Pharmacists Association, American Society for Microbiology, American Society of Health-System Pharmacists, Infectious Diseases Society of America, Society of Infectious Diseases Pharmacists

Disclosure: Received research grant from: Merck & Co., Inc.

Keith M Olsen, PharmD, FCCP, FCCM Dean and Professor, College of Pharmacy, University of Nebraska Medical Center

Disclosure: Nothing to disclose.

Specialty Editor Board

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Chief Editor

Michael Stuart Bronze, MD David Ross Boyd Professor and Chairman, Department of Medicine, Stewart G Wolf Endowed Chair in Internal Medicine, Department of Medicine, University of Oklahoma Health Science Center; Master of the American College of Physicians; Fellow, Infectious Diseases Society of America; Fellow of the Royal College of Physicians, London

Michael Stuart Bronze, MD is a member of the following medical societies: Alpha Omega Alpha, American College of Physicians, American Medical Association, Association of Professors of Medicine, Infectious Diseases Society of America, Oklahoma State Medical Association, Southern Society for Clinical Investigation

Disclosure: Nothing to disclose.

Additional Contributors

Molly Marie Miller, PharmD Pharmacy Resident, Nebraska Medicine

Molly Marie Miller, PharmD is a member of the following medical societies: American College of Clinical Pharmacy, American Pharmacists Association, American Society of Health-System Pharmacists, Nebraska Pharmacists Association, Society of Infectious Diseases Pharmacists

Disclosure: Nothing to disclose.

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