Weekly Update

Weekly Update: June 11 to 24, 2022.

The analysis is updated every two weeks.

New Studies with results available

11 new RCTs with results are available on our website: see here for vaccine et here for treatment

AlQahtani M, Sci Rep, 2022 Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease.
Huygens S, medRxiv, 2022 SARS-CoV-2 hyperimmune globulin for severely immunocompromised patients with COVID-19: a randomised, controlled, double-blind, phase 3 trial
Montgomery H, Lancet Respir Med, 2022 Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial.
NCT04324021 Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
NCT04380519 Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)
NCT04380688 Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
NCT04382586 Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
NCT04409509 Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID‑19)
NCT04411680 Study of Sargramostim in Patients With COVID-19
NCT04551898 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Wolfe CR, Lancet Respir Med, 2022 Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.

Studies pending data extraction

15 new pharmacological and/or preventive RCTs:

Karampitsakos T, medrxiv, 2022 Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial.
Arruda E A G, medrxiv, 2021 Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections
Bargay-Lleonart J, J Clin Med, 2022 Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial.
Hooper AT, medrxiv, 2022 Casirivimab and Imdevimab Treatment in Seropositive, Hospitalized COVID-19 Patients With Non-neutralizing or Borderline Neutralizing Antibodies
Johnson MG, Ann Intern Med, 2022 Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial.
Landoni G, Infect Dis Ther, Infect Dis Ther, 2022 A Multicenter Phase 2 Randomized Controlled Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients with COVID-19 Pneumonia.
Mazzaferri F, medRxiv, 2022 Exploratory data on the clinical efficacy of monoclonal antibodies against SARS-CoV-2 Omicron Variant of Concern
McElvaney OJ, Med (N Y), 2022 A randomized, double-blind, placebo-controlled trial of intravenous alpha-1 antitrypsin for acute respiratory distress syndrome secondary to COVID-19.
McMahon JH, SSRN, 2022 Favipiravir in Early Symptomatic COVID-19, A Randomised Placebo-Controlled Trial
Medhat MA, Arab J Gastroenterol, 2022 Sofosbuvir/ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: A randomized controlled trial for repurposing antivirals.
Mukae H, medrxiv, 2022 A Randomized Phase 2/3 Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-like Protease Inhibitor, in Japanese Patients With Mild-to-Moderate COVID-19 or Asymptomatic SARS-CoV-2 Infection: Results of the Phase 2a Part
Prasenohadi P, J Clin Med, 2022 Double-Blind, Randomized, Placebo-Controlled Study on hzVSF-v13, a Novel Anti-Vimentin Monoclonal Antibody Drug as Add-on Standard of Care in the Management of Patients with Moderate to Severe COVID-19.
Rahman SMA, Clin Infect Pract, 2022 Safety and Efficacy of Favipiravir for the management of COVID-19 Patients: A Randomized Control Trial.
Sivapalasingam Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Pneumonia
Terada J, EClinicalMedicine, 2022 Favipiravir, camostat, and ciclesonide combination therapy in patients with moderate COVID-19 pneumonia with/without oxygen therapy: An open-label, single-center phase 3 randomized clinical trial.

19 new vaccine RCTs under extraction:

Abarca K, medrxiv, 2022 Safety and efficacy of two immunization schedules with an inactivated SARS-CoV-2 vaccine in adults. A randomized non-inferiority clinical trial.
Achiron A, J Neurol, 2022 Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod.
Al Kaabi N, medRxiv, 2022 Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients: a randomized controlled phase 2 trial
Anderson E, Research Square, 2022 Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine An Interim Analysis
Costa Clemens SA, medrxiv, 2022 Homologous and heterologous boosting of the ChAdOx1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, observer-blinded, controlled, phase 2 study
Creech CB, N Engl J Med, 2022 Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age.
Dai L, N Engl J Med, 2022 Efficacy and Safety of the RBD-Dimer-Based Covid-19 Vaccine ZF2001 in Adults.
El Sahly HM, J Infect Dis, 2022 Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 COVE Trial.
Hui AH, SSRN, 2022 Immunogenicity and Safety of BNT162b2 mRNA Vaccine in Chinese Adults: A Randomized Clinical Trial
Jin P, medrxiv, 2022 Heterologous CoronaVac plus Ad5-nCOV versus homologous CoronaVac vaccination among elderly: a phase 4, non-inferiority, randomized study
Khobragade A, Lancet, 2022 Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India.
LAUNAY O, medrxiv, 2022 Immunogenicity and Safety of Beta Adjuvanted Recombinant Booster Vaccine
Madhi SA, Lancet, 2022 Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial.
Masuda T, Vaccine, 2022 Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial.
Munro APS, Lancet Infect Dis, 2022 Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase
Niyomnaitham S, vaccine , 2022 Immunogenicity and reactogenicity against the SARS-CoV-2 variants following heterologous primary series involving CoronaVac and ChAdOx1 and BNT162b2 plus heterologous BNT162b2 booster vaccination: An open-label randomized study in healthy T
Xuan-Yi Wang, SSRN, 2022 Efficacy of Heterologous Boosting Using Recombinant SARS-CoV-2 Fusion Protein Vaccine: A Randomized, Double-Blind and Placebo-Controlled Phase III Trial
Zeng G, Lancet Infect Dis, 2021 Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials
Zhu F, Lancet Respir Med, 2022 Safety and immunogenicity of a live-attenuated influenza virus vector-based intranasal SARS-CoV-2 vaccine in adults: randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

22 early phase vaccine trials where the vaccine dose and schedule have not yet been determined :

Angkasekwinai N, Vaccine, 2021 Comparison of safety and immunogenicity of CoronaVac and ChAdOx1 against the SARS-CoV-2 circulating variants of concern (Alpha, Delta, Beta) in Thai healthcare workers
Anh DD, SSRN, 2022 Safety and Immunogenicity of an Egg-Based Inactivated Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomized, Placebo-Controlled, Phase 1/2 Trial in Vietnam
Butta N, SSRN, 2022 Effect of a COVID-19-Heterologous Vaccination Schedule on Haemostasis: A Subanalysis of the Phase 2, Multicentre, Randomised, Controlled CombiVacS Study
Chen GL, Lancet microbe, 2022 Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial
Chen J, 2021 [A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules].
Chiuppesi F, Lancet Microbe, 2022 Safety and immunogenicity of a synthetic multiantigen modified vaccinia virus Ankara-based COVID-19 vaccine (COH04S1): an open-label and randomised, phase 1 trial.
Dang AD, medrxiv, 2022 Safety and Immunogenicity of An Egg-Based Inactivated Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomized, Placebo-Controlled, Phase 1/2 Trial in Vietnam
Iwata S, SSRN, 2022 Phase 1/2 Clinical Trial of COVID-19 Vaccine in Japanese Participants: A Report of Interim Findings
Launay O, EBioMedicine, 2022 Safety and immunogenicity of a measles-vectored SARS-CoV-2 vaccine candidate, V591 / TMV-083, in healthy adults: results of a randomized, placebo-controlled Phase I study.
Mohraz M, BMJ Open, 2022 Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults.
Mohraz M, BMJ Open, 2022 Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults.
Orozco MN, medrxiv, 2022 Phase I study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B
Pajon R, Nat Med, 2022 Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.
Pitisuttithum P, EClinicalMedicine, 2022 Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial.
Pollock KM, eclinicalmedicine, 2022 Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial
Saez-Llorens X , SSRN, 2021 Safety and Immunogenicity of mRNA-LNP COVID-19 Vaccine CVnCoV in Latin American Adults; A Phase 2 Randomized Study
Song JY , medrxiv, 2022 Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: a phase 1/2, randomized, placebo-controlled, observer-blinded trial
Tabarsi P, CMI, 2022 Safety and immunogenicity of SpikoGen®, an advax-cpg55.2-adjuvanted sars-cov-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations.
Thuluva S, medRxiv, 2022 Selection of optimum formulation of RBD-based protein sub-unit covid19 vaccine (Corbevax) based on safety and immunogenicity in an open-label, randomized Phase-1 and 2 clinical studies
Vanhoutte F, EBioMedicine, 2022 Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial
Wang CY, J Clin Invest, 2022 A multitope SARS-COV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants.
Wynne C, medRxiv, 2022 The preliminary safety and immunogenicity results of a randomized, double-blind, placebo-controlled Phase I trial for a recombinant two-component subunit SARS-CoV-2 vaccine ReCOV

We stopped the living review for vaccine observational studies. Last search date Nov 03,2021. No more studies will be included after this date.

We have identified additional COVID-19 RCTs assessing:

  1. long COVID
  2. other interventions (dietary supplements or minerals and other technologies (e.g. cytokine adsorption)
  3. other COVID vaccines.

These interventions were not prioritized but they might be included in the future. Details here