A Review on Currently Available Potential Therapeutic Options for COVID-19

Figures & data

Figure 1 Schematic representation of the immunopathogenesis of SARS-CoV-2 infection and the potential therapeutic options against COVID-19.

Table 1 Monoclonal Antibodies Under Trials for Evaluation of Efficacy and Safety as Treatment Options of COVID-19 Infection

Identifier Number	Brief Aim of Trial	Study Phase	Study Sponsor/Country	Interventions
NCT04425629	To assess the safety, tolerability, and efficacy of anti-spike monoclonal antibodies for the treatment of ambulatory patients with COVID-19	Phase 1 Phase 2	Regeneron Pharmaceuticals/France	Drug: REGN10933+REGN10987 Drug: placebo
NCT04346277	Using IC14 to block CD14-mediated cellular activation in patients early in the development of ARDS.	-	Implicit Bioscience/Italy	Biological: IC14 (A recombinant chimeric monoclonal antibody against CD14)
NCT04391309	Assess IC14 in reducing the severity of respiratory disease in hospitalized COVID-19 patients	Phase 2	Implicit Bioscience	Biological: IC14 Other: placebo
NCT04409509	To evaluate CSL312 in COVID 19	Phase 2	CSL Behring/United States	Biological: garadacimab, factor XIIa antagonist monoclonal antibody Drug: placebo
NCT04351152	To assess whether the use of lenzilumab + current standard of care (SOC) can alleviate the cytokine release syndrome (CRS) and inhibit development to respiratory failure and/or death in high risk COVID-19 patients	Phase 3	Humanigen, Inc./US	Biological: lenzilumab (anti-human GM-CS monoclonal antibody) Drug: standard of care
NCT04341116	To assess the safety and efficacy of intravenous infusion of TJ003234 in cases with severe COVID-19 under supportive care, and to assess its effect on cytokines levels.	Phase 1 Phase 2	I-Mab Biopharma Co. Ltd/US	Drug: TJ003234 (Anti-GM-CSF monoclonal antibody) Drug: placebo
NCT04432298	To evaluate the efficacy and safety of intravenous pamrevlumab as compared to placebo in hospitalized cases of acute COVID-19.	Phase 2	FibroGen	Drug: pamrevlumab (human recombinant monoclonal antibody against connective tissue growth factor (CTGF) Drug: placebo
NCT04324021	To assess the efficacy and safety of emapalumab or anakinra, vs standard of care (SoC)	Phase 2 Phase 3	Swedish Orphan Biovitrum/Italy	Biological: emapalumab (anti-interferon-gamma (IFNγ) monoclonal antibody) Biological: anakinra (recombinant form of a human receptor antagonist (IL-1ra))
NCT04429529	To assess safety of TY027 as a treatment for COVID-19	Phase 1	Tychan Pte Ltd/Singapore	Biological: TY027 Other: 0.9% saline
NCT04386239	To assess the efficacy and safety of sarilumab in COVID-19 patients	Early Phase 1	ASST Fatebenefratelli Sacco	Drug: sarilumab (human monoclonal antibody against the interleukin-6 receptor) prefilled syringe
NCT04357808	To assess the efficacy and safety of sarilumab for mild to moderate COVID-19 infection	Phase 2	Maria del Rosario Garcia de Vicuña Pinedo/Spain	Drug: sarilumab Other: standard of care
NCT04324073	To assess the therapeutic effect and tolerance of sarilumab in patients with moderate, severe pneumonia or critical COVID-19.	Phase 2 Phase 3	Assistance Publique - Hôpitaux de Paris/France	Drug: sarilumab
NCT04351243	To assess the efficacy and safety of gimsilumab in subjects with acute respiratory distress syndrome secondary to COVID-19.	Phase 2	Kinevant Sciences GmbH/US	Drug: gimsilumab (anti-GM-CSF human monoclonal antibody) Drug: placebo
NCT04343651	To assess the efficacy and safety of leronlimab for mild to moderate COVID-19 infection	Phase 2	CytoDyn, Inc./US	Drug: leronlimab (humanized immunoglobulin (IgG4 monoclonal antibody against CC chemokine receptor 5 (CCR5; CD195) Drug: placebos (700 mg)
NCT04347239	To assess the efficacy and safety of leronlimab for patients with severe COVID-19 infection	Phase 2	CytoDyn, Inc./US	Drug: leronlimab (700 mg) Drug: placebos
NCT04305106	To assess the efficacy and safety of bevacizumab for severe and critical COVID-19 patients.	NA	Qilu Hospital of Shandong University/China	Drug: bevacizumab (humanized anti-VEGF monoclonal antibody)
NCT04413838	To assess the efficiency and security of nivolumab therapy in obese individuals with COVID-19 infection		Hospices Civils de Lyon/France	Drug: nivolumab (fully human IgG4 (S228P) monoclonal antibody) Other: routine standard of care
NCT04435184	To assess the efficacy and safety of crizanlizumab in hospitalized patients with COVID-19 infection.	Phase 2	Johns Hopkins University/US	Drug: crizanlizumab (anti-P-selectin monoclonal antibody) Other: 0.9% saline
NCT04377750	To assess the efficacy and safety of tocilizumab in the treatment of severe COVID-19 cases with suspected pulmonary hyperinflammation	Phase 3	Hadassah Medical Organization/Israel	Drug: tocilizumab (humanized monoclonal antibody against the IL-6 receptor)
NCT04331808	To assess the therapeutic effect and tolerance of tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with COVID-19 infection	Phase 2	Assistance Publique - Hôpitaux de Paris/France	Drug: tocilizumab
NCT04330638	To compare the efficacy of combinations of anti-IL drugs to best standard of care in treatment of patients with severe COVID-19	Phase 3	University Hospital, Ghent/Belgium	Other: usual care Drug: anakinra Drug: siltuximab Drug: tocilizumab
NCT04341584	To compare the efficacy of anakinra in patients with Covid-19 infection	Phase 2	Assistance Publique - Hôpitaux de Paris/France	Drug: anakinra
NCT04397497	To assess the efficacy and safety of mavrilimumab in hospitalized patients with severe COVID- 19 infection and a hyper-inflammatory status.	Phase 2	Ospedale San Raffaele/Italy	Drug: mavrilimumab (human monoclonal antibody against GM-CSF-R) Drug: placebo
NCT04390464	To assess the potential treatment effect for COVID-19 disease (repurposed drugs)	Phase 4	Cambridge University Hospitals NHS Foundation Trust/UK	Drug: ravulizumab (humanized monoclonal antibody against C5) Drug: baricitinib Other: standard of care
NCT04369469	To evaluate the efficacy and safety of intravenous ravulizumab compared to best supportive care in patients with COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome	Phase 3	Alexion Pharmaceuticals	Biological: ravulizumab Other: best supportive care
NCT04322773	To assess the effectiveness of IL-6 receptor inhibitors in the tratment of patients with severe COVID-19 infection.	Phase 2	Marius Henriksen/Denmark	Drug: tocilizumab(RoActemra) iv (humanized monoclonal antibody against the IL-6 receptor) Drug: tocilizumab(RoActemra) sc Drug: sarilumab (Kevzara) sc (humanized monoclonal antibodyagainst the IL-6 receptor) Other: standard medical care
NCT04365153	To assess whether early treatment with canakinumab inhibits progressive heart and respiratory failure in patients with COVID-19 infection	Phase 2	The Cleveland Clinic/US	Drug: canakinumab (human monoclonal anti-IL-1β antibody) injection 600 mg Drug: canakinumab Injection 300 mg Drug: placebos

Table 2 The Clinical Trials to Evaluate Whether Vaccination has any Effect on Prevention and/or Clinical Progression of COVID-19 Infection

Identifier Number	Aim/Study Population	Phase	Sponser/Country	Intervention/Treatment
NCT04435379	To assess whether vaccination of elderly with VPM1002 could decrease hospital admissions and/or severe respiratory infectious diseases	Phase 3	Vakzine Projekt Management GmbH/Germany	Biological: VPM1002 Biological: placebo
NCT04387409	To assess whether vaccination of health-care professionals with VPM1002 could decrease the number of days absent from work due to respiratory disease	Phase 3	Vakzine Projekt Management GmbH/Germany	Biological: VPM1002 Biological: placebo
NCT04348370	To assess the efficacy of BCG vaccine for HCWs	Phase 4	Texas A&M University/United States	Biological: BCG vaccine Biological: placebo
NCT04373291	To assess protective effect BCG vaccine in HCWs against COVID-19	Phase 3	Bandim Health Project	Biological: BCG-Denmark Biological: saline
NCT04384549	To assess efficacy of BCG vaccine in the prevention of COVID-19 in HCWs	Phase 3	Assistance Publique - Hôpitaux de Paris/France	Biological: BCG vaccine Biological: placebo
NCT04414267	To validate whether vaccination of individuals susceptible to COVID-19 with BCG vaccine can reduce their disease susceptibility (using both clinical and immunological criteria)	Phase 4	Hellenic Institute for the Study of Sepsis/Greece	Biological: BCG vaccine Biological: placebo
NCT04369794	To assess the effect of former (the titer of anti-BCG IFN-γ) or recent BCG exposure (boost with intradermal vaccine) on clinical progression of disease	Phase 4	University of Campinas/Brazil	Biological: BCG vaccine Biological: placebo
NCT04327206	To assess the effect BCG vaccination in protection of HCWs following against COVID-19	Phase 3	Murdoch Childrens Research Institute/Australia	Biological: BCG vaccine Drug: placebo 0.9% NaCl
NCT04347876	To assess whether previous BCG vaccination may modify the prognosis in COVID-19 positive cases	Observational	Assiut University/Egypt	Diagnostic test: tuberculin test
NCT04417335	To assess the whether BCG vaccine can decrease hospital admission and improve the clinical course of COVID-19 infection in elderly individuals (≥60 years old).	Phase 4	Radboud University/Netherlands	Biological: BCG vaccine Biological: placebo
NCT04350931	To assess whether previous BCG vaccination can be used as immune-prophylaxis among Egyptian HCWs against COVID-19 infection	Phase 3	Ain Shams University/Egypt	Biological: intradermal injection of BCG vaccine Other: placebo
NCT04379336	To assess whether BCG vaccine can decrease morbidity and mortality in HCWs exposed to SARS-CoV-2	Phase 3	TASK Applied Science/South Africa	Biological: BCG Other: placebo
NCT04362124	To assess if BCG vaccination in HCWs can decrease the severity of COVID-19 Infection	Phase 3	Universidad de Antioquia/Colombia	Biological: BCG vaccine Biological: placebo
NCT04328441	To reduce absenteeism among HCWs with direct patient contacts during the epidemic phase of COVID-19. Secondary objective: to reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of COVID-19.	Phase 3	UMC Utrecht/Netherlands	Biological: BCG vaccine Biological: placebo

Abbreviations: HCWs, health-care workers; BCG, Bacillus Calmette–Guérin.