COVID-19 (coronavirus disease 2019) is a respiratory tract infection with a newly recognized coronavirus thought to have originated as a zoonotic virus that has mutated or otherwise adapted in ways that allow human pathogenicity, the disease was provisionally called 2019-nCoV infection at start of outbreak (2019 novel coronavirus infection). This outbreak began in China but has since spread to many other countries; it was officially declared by WHO to be a pandemic 1 on March 11, 2020. The illness ranges in severity from asymptomatic or mild to severe; a significant proportion of patients with clinically evident infection develop severe disease. The mortality rate among diagnosed cases (case fatality rate) is generally about 2% to 3% but varies by country; true overall mortality rate is uncertain, as the total number of cases (including undiagnosed persons with milder illness) is unknown. The knowledge of this disease is incomplete and evolving; moreover, coronaviruses are known to mutate and recombine often, presenting an ongoing challenge to our understanding and to clinical management.

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The infection should be suspected based on presentation with a clinically compatible history and known or likely exposure (eg, residence in or travel to an affected area within the past 14 days, exposure to a known or suspected case, and exposure to a health care setting in which patients with severe respiratory tract infections are managed). The chest imaging in symptomatic patients almost always shows abnormal findings, usually including bilateral infiltrates; laboratory findings are variable but typically include lymphopenia and elevated lactate dehydrogenase and transaminase levels. Diagnosis is confirmed by detection of viral RNA on polymerase chain reaction test of upper or lower respiratory tract specimens or serum specimens. There is no specific antiviral therapy, although compassionate use and trial protocols for several agents are underway; treatment is largely supportive, consisting of supplemental oxygen and conservative fluid administration. The most common complications are Acute Respiratory Distress Syndrome and Septic Shock; Myocardial, Renal, and multiorgan failure have been reported. There is no vaccine available to prevent this infection; infection control measures are the mainstay of prevention (i.e., hand and cough hygiene; physical distancing; standard, contact, and airborne precautions in health care).

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The pipeline of COVID-19 consists of approximately 86 products in different stages of development. It includes therapeutic drugs and vaccines under by companies. Currently, 8 therapeutic drugs are in Phase III and 8 are in Phase II stage of development, however major drugs are in pre-clinical stage. Moreover, 3 vaccines are in Phase I trial, and 37 vaccines are in Pre-clinical stage being under development by companies. Currently the therapeutic pipeline of COVID-19 consists of approximately 23 clinical products in different stages of development and major drugs are in pre-clinical stage. Emerging treatment strategies for COVID-19 disease involve the development of small molecule compounds, peptides & proteins and monoclonal antibodies among other which are widely used for the treatment of a variety of diseases. The key players involved in the development of products for the treatment of COVID-19 in Phase III and II stage include Ascletis Pharma Inc., OncoImmune, FUJIFILM Toyama Chemical Co., Ltd., Sanofi, Gilead Sciences, Incyte Corporation, Hoffmann La Roche, Vanda Pharmaceuticals Apeiron Biologics, Relief Therapeutics Holdings, Bioxytran Inc., CytoDyn, AbbVie, PharmaMar, Sanofi-Aventis and Synairgen Research.

The development and launch of these therapies are expected to lead to the better treatment and longer life span of the individuals with COVID-19.

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TABLE OF CONTENTS:

1. REPORT INTRODUCTION

1.1 Objective of the Study 12

1.2 Limitation 12

1.3 Stakeholders 12

1.4 Currency used in the Report 12

1.5 Secondary Research 12

1.6 Scope of the COVID-19 – Pipeline Analysis Study 12

2. RESEARCH METHODOLOGY OR ASSUMPTION 14

2.1 Research Methodology for the COVID-19 – Pipeline Analysis 2020 14

2.1.1 Main objective of the COVID-19 – Pipeline Analysis 2020 14

3. EXECUTIVE SUMMARY 16

4. DISEASE OVERVIEW 18

4.1 Introduction 18

4.2 Etiology 19

4.3 Virology 19

4.3.1 Physicochemical Properties 21

4.3.2 Receptor Interactions and Cell Entry 21

4.4 Diversity of Coronaviruses 22

4.5 Epidemiology and clinical features of human coronaviruses 22

4.5.1 Source of Infection 22

4.5.2 Spectrum of Infection 22

4.5.3 Clinical Features 23

4.5.4 Epidemiological Characteristics in Mainland China and other countries 24

4.5.5 Herd Susceptibility 25

4.6 Pathogenesis 25

4.6.1 Virus Entry and Spread 25

4.6.2 Pathological Findings 26

4.6.3 Acute Respiratory Distress Syndrome (ARDS) 26

4.6.4 Cytokine Storm 26

4.6.5 Immune Dysfunction 27

4.7 Signs and Symptoms 29

4.8 Diagnostic testing 31

4.8.1 Nucleic Acid Test 48

4.8.2 Serologic Diagnosis 49

4.8.3 CRISPR/Cas13 System 49

4.8.4 Imaging Technology 49

4.9 Treatment 50

4.9.1 Type I IFNs 50

4.9.2 Convalescent Plasma 53

4.9.3 Protective Monoclonal Antibody 53

4.9.4 Protease 53

4.9.5 Others 54

4.9.6 Vaccines 54

4.9.7 Proposed COVID-19 Triage Algorithm for Low-income Settings Without Established Local Transmission 56

5. PIPELINE THERAPEUTICS AT A GLANCE 57

5.1 General Overview (Clinical Stage Products) 57

5.2 General Overview (Non-Clinical Stage Products 58

6. CLINICAL PRODUCTS UNDER DEVELOPMENT BY TARGET 59

7. COMPARATIVE ANALYSIS 61

7.1 General Overview 61

8. LATE PHASE PRODUCTS (PHASE III) 62

8.1 Comparative Analysis 62

8.2 ASC09+Ritonavir: Ascletis Pharmaceuticals Co., Ltd. 63

8.2.1 Product Description 63

8.2.2 Research and Development 63

8.2.2.1 Clinical Studies 63

8.2.2.1.1 Phase III 63

8.2.3 Product Development Activities 64

8.2.3.1 Collaboration 64

8.3 CD24Fc: OncoImmune 66

8.3.1 Product Description 66

8.3.2 Research and Development 67

8.3.2.1 Clinical Studies 67

8.3.2.1.1 Phase III 67

8.4 Favipiravir: FUJIFILM Toyama Chemical Co., Ltd. 69

8.4.1 Product Description 69

8.4.2 Research and Development 70

8.4.2.1 Clinical Studies 70

8.4.2.1.1 Phase III 70

8.5 Hydroxychloroquine: Sanofi-Aventis 72

8.5.1 Product Description 72

8.5.2 Research and Development 72

8.5.2.1 Clinical Studies 72

8.5.2.1.1 Phase III 72

8.6 Remdesivir: Gilead Sciences 76

8.6.1 Product Description 76

8.6.2 Research and Development 76

8.6.2.1 Pre-clinical Studies 76

8.6.2.2 Clinical Studies 77

8.6.2.2.1 Phase III 77

8.7 Ruxolitinib: Incyte Corporation 79

8.7.1 Product Description 79

8.7.2 Research and Development 79

8.7.2.1 Clinical Studies 79

8.7.2.1.1 Phase III 79

8.7.3 Product Development Activities 80

8.7.3.1 Collaboration Agreement 80

8.8 Tocilizumab: Hoffmann-La Roche 82

8.8.1 Product Description 82

8.8.2 Research and Development 83

8.8.2.1 Clinical Studies 83

8.8.2.1.1 Phase III 83

8.9 Tradipitant: Vanda Pharmaceuticals 85

8.9.1 Product Description 85

8.9.2 Research and Development 86

8.9.2.1 Clinical Studies 86

8.9.2.1.1 Phase III 86

8.9.3 Product Development Activities 86

8.9.3.1 Licensing Agreement 86

8.9.3.2 Patent 86

9. MID PHASE PRODUCTS (PHASE II) 88

9.1 Comparative Analysis 88

9.2 APN-01: Apeiron Biologics 89

9.2.1 Product Description 89

9.2.2 Research and Development 90

9.2.2.1 Clinical Studies 90

9.2.2.1.1 Phase II 90

9.2.3 Product Development Activities 90

9.2.3.1 Acquisition Agreement 90

9.3 Aviptadil: Relief Therapeutics 92

9.3.1 Product Description 92

9.3.2 Research and Development 92

9.3.2.1 Clinical Studies 92

9.3.2.1.1 Phase II 92

9.3.3 Product Development Activities 92

….continued

Contact Details:

NORAH TRENT

[email protected]

Ph: +162-825-80070 (US)

Ph: +44 2035002763 (UK)

971 0503084105