Weekly Update

Weekly Update: January 9, 2022 to January 27, 2023.

New Studies with results available

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

Al Kaabi N, Signal Transduct. Ther., 2023 Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants: a randomized phase 2 trial
Anderson E, Research Square, 2022 Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine An Interim Analysis
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
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
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
Jilg N, Top. antivir. Med, 2022b CAMOSTAT IS NOT EFFECTIVE for MILD-MODERATE COVID-19 in A PHASE 2 TRIAL of ACTIV-2
Kho MML, Lancet Infect Dis, 2022 Alternative strategies to increase the immunogenicity of COVID-19 vaccines in kidney transplant recipients not responding to two or three doses of an mRNA vaccine (RECOVAC): a randomised clinical trial.
LAUNAY O, medrxiv, 2022 Immunogenicity and Safety of Beta Adjuvanted Recombinant Booster Vaccine
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
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
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.
Taiwo BO, Top. antivir. Med, 2022 PHASE-2 STUDY of SAB-185, A POLYCLONAL ANTIBODY TREATMENT for COVID-19 in ACTIV-2
Tanriover MD, Vaccines (Basel), 2022 Efficacy, Immunogenicity, and Safety of the Two-Dose Schedules of TURKOVAC versus CoronaVac in Healthy Subjects: A Randomized, Observer-Blinded, Non-Inferiority Phase III Trial.

Studies pending data extraction

22 new pharmacological RCTs:

Cabral P, ResearchSquare, 2022 Serial Viral Load Analysis by Ddpcr to Evaluate Fnc Efficacy and Safety in the Treatment of Mild Cases of Covid-19
Cafardi J, JAMA Netw Open, 2022 Efficacy and Safety of Pacritinib vs Placebo for Patients With Severe COVID-19: A Phase 2 Randomized Clinical Trial.
Corral-Gudino L, Eur J Clin Invest, 2022 Effect of intravenous pulses of methylprednisolone 250 mg versus dexamethasone 6 mg in hospitalized adults with severe COVID-19 pneumonia: an open-label randomized trial
Denkinger C M, medrxiv, 2022 Anti-SARS-CoV-2 antibody containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19 via increased neutralizing antibody activity. A randomized clinical trial
Hepprich M, EClinicalMedicine, 2022 Canakinumab in patients with COVID-19 and type 2 diabetes - A multicentre, randomised, double-blind, placebo-controlled trial
Ilaria Mastrorosa I, SSRN, 2022 Sarilumab Plus Standard of Care Versus Standard of Care for the Treatment of Severe COVID-19: A Phase 3, Randomized, Open-Labeled, Multi-Center Study (ESCAPE Study)
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
Jittamala P, medrxiv, 2022 Clinical antiviral efficacy of remdesivir and casirivimab/imdevimab against the SARS-CoV-2 Delta and Omicron variants
Ko ER, medrxiv, 2022 Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19
McMahon JH, EClinicalMedicine, 2022 Favipiravir in early symptomatic COVID-19, a randomised placebo-controlled trial
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)
O'Halloran J, medrxiv, 2022 Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19
Rein L, Crit Care Med, 2022 Randomized Phase 3 Trial of Ruxolitinib for COVID-19-Associated Acute Respiratory Distress Syndrome
Salton F, Eur Respir J, 2022 Prolonged higher dose methylprednisolone vs. conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS).
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
Terada J, Drug Discov Ther, 2022 Impact of inhaled ciclesonide on asymptomatic or mild COVID-19: a randomized 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
Wu H, PloS one, 2022 Low-dose versus high-dose dexamethasone for hospitalized patients with COVID-19 pneumonia: a randomized clinical trial

4 conference abstracts:

Arends EJ,J. Am. Soc. Nephrol, 2022 Antiviral Effects of Voclosporin on SARS-CoV-2 in Immunocompromised Kidney Patients
Jalili E, Tanaffos, 2022 (PRESECO) Effect of Convalescent Plasma Therapy on Clinical Improvement of COVID-19 Patients: a Randomized Clinical Trial
Mastrorosa I, Top. antivir. Med, 2022 SARILUMAB PLUS STANDARD of CARE (SOC) VERSUS SOC for SEVERE COVID-19 (ESCAPE STUDY)
Muller-Tidow C, Hemasphere, 2022 A RANDOMIZED CONTROLLED CLINICAL TRIAL DEMONSTRATES THAT PLASMA FROM CONVALESCENT AND VACCINATED DONORS IMPROVES OUTCOME OF COVID-19 IN PATIENTS WITH HEMATOLOGICAL DISEASE, CANCER OR IMMUNOSUPPRESSION

22 new vaccine RCTs under extraction:

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 EJ, N Engl J Med, 2022a Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age
Anez G, medrxiv, 2022 Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: a Randomized, Phase 3 Trial
BioNTech SE NCT04816669,2022a Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Lyophilized Formulation of BNT162b2 Against COVID-19 in Healthy Adults
Charland N, NPJ Vaccines, 2022a Safety and immunogenicity of an AS03-adjuvanted plant-based SARS-CoV-2 vaccine in Adults with and without Comorbidities.
Cinza-Estevez Z, SSRN, 2022 Immunogenicity and Safety Assessment of a SARS-CoV-2 Recombinant Spike RBD Protein Vaccine (Abdala) in Paediatric Ages 3 to 18 Years Old: A Double-Blinded, Multicentre, Randomised, Phase 1/2 Clinical Trial (ISMAELILLO Study)
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
Janssen Vaccines & Prevention ,2023a A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
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
Leung N H L, medrxiv, 2022 Homologous and heterologous boosting with CoronaVac and BNT162b2: a randomized trial (the Cobovax study)
Li G, Lancet, 2022 b Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial.
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
ModernaTX, Inc, 2022a Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older
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
Niyomnaitham S, medrxiv, 2022 Immune responses of the third dose of AZD1222 vaccine or BNT162b2 mRNA vaccine after two doses of CoronaVac vaccines against Delta and Omicron variants
Niyomnaitham S, vaccines, 2022 Evaluation of the Safety and Immunogenicity of Fractional Intradermal COVID-19 Vaccines as a Booster: a Pilot Study
Omma A, Hum Vaccin Immunother, 2022 Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial
Tang R, SSRN, 2022 Safety and Immunogenicity of Aerosolised Ad5-nCoV or Intramuscular Ad5-nCoV or Inactivated COVID-19 Vaccine Coronavac Given as the Second Booster Following Three Doses of CoronaVac: A Multicentre, Open-Label, Phase 4, Randomized Trial
Wang L, SSRN, 2022 Safety and Cross-Reactive Immune Response Against the Omicron Variant of a Third Dose of CoronaVac, and Immune Persistence of Primary Immunization in Healthy Children and Adolescents: Interim Results from a Double-Blind, Randomised, Placebo
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

41 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.
Alcamí Pertejo J, SSRN, 2022 Immunogenic Dynamics and SARS-CoV-2 Variants Neutralization of the Heterologous ChAdOx1-S/BNT162b2 Vaccination: Secondary Analysis of the CombiVacS Study
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
Baden L, N Engl J Med, 2021 Phase 3 Trial of mRNA-1273 during the Delta-Variant Surge
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.
Capone S, medrxiv, 2022 GRAd-COV2 vaccine provides potent and durable immunity in a randomised placebo-controlled phase 2 trial (COVITAR)
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.
Han BH, , Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine], 2022 Safety of an inactivated 2019-nCoV vaccine (Vero) in adults aged 60 years and older
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.
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
Li J, Adv Therap, 2022 Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 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.