Weekly Update

Weekly Update: October 22 to November 3, 2022.

New Studies with results available

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

ACTIV-3/TICO Study Group, Ann Intern Med, 2022 Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.
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
Nantanee R, Vaccine, 2022 A Randomized Clinical Trial of a Fractional Low Dose of BNT162b2 Booster in Adults Following AZD1222.

Studies pending data extraction

18 new pharmacological RCTs:

Adhikari P, Int. J. Infect. Dis, 2022 Efficacy of Favipiravir in treatment of mild & moderate COVID-19 infection in Nepal: a multi-center, randomized, open-labelled, phase III clinical trial
Audemard-Verger A, PloS one, 2022 Efficacy and safety of anakinra in adults presenting deteriorating respiratory symptoms from COVID-19: A randomized controlled trial.
Golan Y, Clin Infect Dis, 2022 Favipiravir in patients with early mild-to-moderate COVID-19: a randomized controlled trial
Jayanthi CR, Adv. Ther, 2022 Efficacy and Safety of Inosine Pranobex in COVID-19 Patients: a Multicenter Phase 3 Randomized Double-Blind, Placebo-Controlled Trial
Ko ER, medrxiv, 2022 Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19
NCT04354428 Treatment for SARS-CoV-2 in High-Risk Adult Outpatients
NCT04427501 A Study of LY3819253 (LY-CoV555) in Participants With Early Mild to Moderate COVID-19 Illness
NCT04448756 M5049 Study in Participants With Coronavirus Disease 2019 (COVID-19) Pneumonia
NCT04472494 Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
NCT04480424 Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
NCT04575038 CRISIS2: A Phase 2 Study Assessing the Safety and Antiviral Activity of Brequinar in SARS-CoV-2 Out-patients
NCT04709835 Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
O'Halloran J, medrxiv, 2022 Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19
Portal Celhay C, JAMA OPEN, 2022 Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection
Tehrani S, Mediterr. J. Infect. Microbes Antimicrob, 2022 Efficacy of Favipiravir in the Treatment of Moderate COVID-19 Patients: a Randomized, Open-label, Controlled Clinical Trial
Thorlacius-Ussing L, Sci Rep, 2022 A randomized placebo-controlled trial of convalescent plasma for adults hospitalized with COVID-19 pneumonia.
Ullah S, Medicina (Kaunas), 2022 Assessment of Tocilizumab (Humanized Monoclonal Antibody) for Therapeutic Efficacy and Clinical Safety in Patients with Coronavirus Disease (COVID-19)
Villanueva C, medrxiv, 2022 Efficacy and safety of convalescent plasma versus standard care in hospitalized patients with COVID-19 from the Peruvian Social Security Health System: open-label, randomized, controlled clinical trial

7 conference abstracts:

Evering TH, Open Forum Infect. Dis., 2021 Safety and Efficacy of Combination SARS-CoV-2 Monoclonal Neutralizing Antibodies (mAb) BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients
Jalili E, Tanaffos, 2022 (PRESECO) Effect of Convalescent Plasma Therapy on Clinical Improvement of COVID-19 Patients: a Randomized Clinical Trial
Siami Z, Iran. Red Crescent Med. J, 2022 Efficacy and safety of atazanavir/ritonavir versus lopinavir/ritonavir in hospitalized COVID-19 patients: a randomized clinical trial
Taiwo BO, Top. antivir. Med, 2022 PHASE-2 STUDY of SAB-185, A POLYCLONAL ANTIBODY TREATMENT for COVID-19 in ACTIV-2

24 new vaccine RCTs under extraction:

Al Kaabi N, medrxiv, 2022 Safety and immunogenicity of a broad-spectrum mosaic vaccine as a booster dose against SARS-CoV-2 Omicron and other circulating variants
Al Kaabi N, Nat Commun, 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
Anez G, medrxiv, 2022 Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: a Randomized, Phase 3 Trial
Bánki Z, EBioMedicine, 2022 Heterologous ChAdOx1/BNT162b2 vaccination induces stronger immune response than homologous ChAdOx1 vaccination: The pragmatic, multi-center, three-arm, partially randomized HEVACC trial.
Chen CJ, Nat Commun, 2022 A randomized controlled trial of heterologous ChAdOx1 nCoV-19 and recombinant subunit vaccine MVC-COV1901 against COVID-19
Corominas J, medRxiv, 2022 Safety and immunogenicity of the protein-based PHH-IV compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial.
Fadlyana E, SSRN, 2022 Immunogenicity and Safety in Healthy Adults of Full-Dose Versus Half Doses of COVID-19 Vaccine (ChAdOx1-S or BNT162b2) or Full-Dose CoronaVac Administered as a Booster Dose after Priming with Coronavac: A Randomized, Observer-Blinded, Contr
Huang LM, Research Square, 2022 Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: A double-blind, randomized, placebo-controlled phase 2 trial
Kulkarni PS, SSRN, 2022 Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study
Kundro MA, Public Health Pract (Oxf), 2022 Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: a randomised clinical trial in an elderly population
LAUNAY O, medrxiv, 2022 Immunogenicity and Safety of Beta Adjuvanted Recombinant Booster Vaccine
Leung N H L, medrxiv, 2022 Homologous and heterologous boosting with CoronaVac and BNT162b2: a randomized trial (the Cobovax study)
Lien CE, SSRN, 2022 A Phase I, Prospective, Randomized, Open-Labeled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Booster Dose with MVC-COV1901 or MVC-COV1901(Beta) SARS-CoV-2 Vaccine in Adults
Madhi, Lancet HIV, 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
Mrak D, Nat Commun, 2022 Heterologous vector versus homologous mRNA COVID-19 booster vaccination in non-seroconverted immunosuppressed patients: a randomized controlled trial.
Niyomnaitham S, Hum Vaccin Immunother, 2022 Immunogenicity and reactogenicity against the SARS-CoV-2 variants following heterologous primary series involving CoronaVac, ChAdox1 nCov-19 and BNT162b2 plus BNT162b2 booster vaccination: An open-label randomized study in healthy Thai adul
Puthanakit T; Vaccine: X; 2022 Heterologous Prime-boost of SARS-CoV-2 Inactivated Vaccine and mRNA BNT162b2 among Healthy Thai Adolescents.
Rose W, SSRN, 2022 Immunogenicity and Safety of Homologous and Heterologous Booster Vaccination of ChAdOx1 nCoV-19 (COVISHIELDTM) and BBV152 (COVAXIN®) in Previous Recipients of COVISHIELDTM or COVAXIN®: A Phase 4, Participant and Observer Blinded, Randomis
Sung JC, Vaccines, 2022 Safety and Immunogenicity of Inactivated Bacillus subtilis Spores as a Heterologous Antibody Booster for COVID-19 Vaccines.
Tabarsi P, Clin Microbiol Infect, 2022 Evaluating the Efficacy and Safety of SpikoGen®, an Advax-CpG55.2-adjuvanted SARS-CoV-2 Spike Protein Vaccine: a Phase 3 Randomized Placebo-Controlled 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.
Tabarsi P, Immunology, 2022 Immunogenicity and Safety of SpikoGen®, an Adjuvanted Recombinant SARS-CoV-2 Spike Protein vaccine as a Homologous and Heterologous Booster Vaccination: A Randomized Placebo-Controlled Trial.
Zhang Y, EClinicalMedicine, 2022 Immunogenicity, durability, and safety of an mRNA and three platform-based COVID-19 vaccines as a third dose following two doses of CoronaVac in China: a randomised, double-blinded, placebo-controlled, phase 2 trial

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

Abarca K, Vaccines, 2022 Safety and efficacy of two immunization schedules with an inactivated SARS-CoV-2 vaccine in adults. A randomized non-inferiority clinical trial.
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
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
Cao Y, Sci China Life Sci, 2022 A third high dose of inactivated COVID-19 vaccine induces higher neutralizing antibodies in humans against the Delta and Omicron variants: a Randomized, Double-Blinded Clinical Trial.
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.
Duc Dang A, Vaccine, 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.
Follmann D, Ann Intern Med, 2022 Antinucleocapsid Antibodies After SARS-CoV-2 Infection in the Blinded Phase of the Randomized, Placebo-Controlled mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial.
Garcia-Perez J, eClinicalMedicine, 2022 Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study.
Iwata S, Vaccine, 2022 Phase 1/2 Clinical Trial of COVID-19 Vaccine in Japanese Participants: A Report of Interim Findings
Jin P, PLoS med, 2022 Safety and immunogenicity of heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001): A randomized, observer-blinded, placebo-controlled trial.
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.
Leal L, medrxiv, 2022 Safety and Immunogenicity of a Recombinant Protein RBD Fusion Heterodimer Vaccine against SARS-CoV-2: preliminary results of a phase 1-2a dose-escalating, randomized, double-blind clinical trial
Lin KY, J Formos Med Assoc, 2022 Serological response after COVID-19 mRNA-1273 booster dose in immunocompromised patients, Taiwan, July to August 2021.
Luo D, Clin Transl Med, 2022 A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults.
Marchevsky NG, eBioMedicine, 2022 An exploratory analysis of the response to ChAdOx1 nCoV-19 (AZD1222) vaccine in males and females.
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.
NCT04569786 Dose Ranging Trial to Assess Safety and Immunogenicity of V590 in Healthy Adults (V590-001)
Orozco MN, medrxiv, 2022 Phase I study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B
Ozdarendeli A, SSRN, 2022 Safety and Immunogenicity of an Inactivated Whole Virion SARS-CoV-2 Vaccine, TURKOVAC, in Healthy Adults: Interim Results from Randomised, Double-Blind, Placebo-Controlled Phase 1 and 2 Trials
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
Puthanakit T, vaccines, 2022 Immunogenicity of a Fractional Dose of mRNA BNT162b2 COVID-19 Vaccine for Primary Series and Booster Vaccination among Healthy Adolescents.
Robbins JA, eBioMedicine, 2022 Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, 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, EClinicalMedicine, 2022 Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial.
Tanishima M, medRxiv, 2022 Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, KD-414, in healthy adult and elderly subjects: a randomized, double-blind, placebo-controlled, phase 1/2 clinical study in Japan
Thuluva S, EBioMedicine, 2022 Evaluation of safety and immunogenicity of receptor-binding domain-based COVID-19 vaccine (Corbevax) to select the optimum formulation in open-label, multicentre, and randomised phase-1/2 and phase-2 clinical trials
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
Waits A, Int J Infect Dis, 2022 Safety and Immunogenicity of MVC-COV1901 Vaccine in Older Adults: phase 2 Randomized Dose-Comparison 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
Xia S, Front Immunol, 2022 Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial.
Zhu, 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

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